Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100103
SPECIALTY ASSAYED CONTROL-2 · Helena Laboratories · decided 2010-12-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| REAADS Coagulation Control 2 | 702-001 | CORGENIX MEDICAL CORPORATION | GGC | 00855360006250 |
| Coagulation S.A.C.-2 (Specialty Assay Control) | 5302 | HELENA LABORATORIES CORPORATION | GGC | M52553020 |