Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| QuikScreen | 65C09-5 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LCM LDJ | 00748349000151 |
| QuikScreen | 65917-19 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DJR DKZ JXM | 00748349000229 |
| QuikScreen Multi 11 Drug Cup Test | 60B00 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LDJ LFH | 00748349000106 |
| QuikScreen | 60A41 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJD DJG DJR DKZ JXN LCM | 00748349000342 |
| ACCUTEST Drug Test Cup 11-Panel CLIA-Waived | DS811 | JANT PHARMACAL CORPORATION | DIO DIS DJC DJG DJR DKZ JXM LCM LDJ LFH | 10763924811530 |
| QuikScreen 11+3 Drug Cup Test | 65B14-10 | SYNTRON BIORESEARCH, INC. | DIS DJC DJG DJR DKZ JXM LCM LDJ | 00748349000014 |
| QuikScreen 7+4 | 65732-7 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DJR DKZ LDJ | 00748349000724 |
| QTEST 7 (25 Pack) | DOA-7QT | MEDIMPEX UNITED, INC | DIO DJC DJG DKZ JXM LDJ | 10864040000324 |
| QuikScreen | 60719 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DJR DKZ LDJ | 00748349000137 |
| QuikScreen | 60C21 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LCM LDJ LFH | 00748349000274 |
| Status Toxi Cup | 65C13+4 | Lifesign L.L.C. | DIO DIS DJC DJG DKZ JXM LCM LDJ LFH | 00868348000256 |
| QuikScreen | 60B16 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LCM LFH | 00748349000199 |
| QuikScreen | 65810-11 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DJR DKZ LDJ | 00748349000144 |
| QuikScreen | 60A42 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LCM LFH | 00748349000243 |
| ACCUTEST - 5 Drug Test Cup *CLIA-Waived* | DS86S625 | JANT PHARMACAL CORPORATION | DIO DJG DKZ LCM LFH | 10763924086532 |
| QuikScreen Multi 12 Drug Cup Test | 60C09 | SYNTRON BIORESEARCH, INC. | DIO DIS DJC DJG DJR DKZ JXM LCM LDJ LFH | 00748349000175 |
| QuikScreen | 60510 | SYNTRON BIORESEARCH, INC. | DIO DJG DKZ JXM LFH | 00748349000113 |
| QuikScreen | 60554 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG JXM LDJ | 00748349000281 |
| QuikScreen | 65646-19 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DKZ JXM LDJ | 00748349000298 |
| QTEST 11 (25 pack) | DOA-11Ca | MEDIMPEX UNITED, INC | DIO DIS DJC DJG DJR DKZ JXM LCM LDJ LFH | 10864040000331 |
| ACCUTEST - 6 Drug Cup | DS87S625 | JANT PHARMACAL CORPORATION | DIO DJC DJG DKZ LCM LFH | 10763924087539 |
| Quikscreen | 60411 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG LDJ | 00748349000335 |
| QuikScreen | 60827 | SYNTRON BIORESEARCH, INC. | DIO DJC DJG DJR JXM LDJ | 00748349000304 |
| QuikScreen 5 Drug Cup Test | 60505 | SYNTRON BIORESEARCH, INC. | DIO DJG DKZ LCM LDJ | 00748349000052 |
| LifeSign QuikScreen 11 | 60B02 | Lifesign L.L.C. | DIO DIS DJC DJG DJR DKZ JXM LDJ LFH | 00863480002106 |