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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K182701

Wondfo T-Cup Multi-Drug Urine Test Cup · Guangzhou Wondfo Biotech Co., Ltd. · decided 2018-12-03 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Prime ScreenDTDOA-274-25BX-AWONDFO USA CO., LTD.NFT NFV NFW NFY NGG NGL00816862024913
iScreen™ABTDUAK110701AInstant Technologies, Inc.LCM NFT NFV NFW NFY NGG NGL PTG PTH00817405023486
MedlineMPHD141A3CMEDLINE INDUSTRIES, INC.NFT20193489017554
iScreen™ABTDUAW15701AInstant Technologies, Inc.NFT NFW NFY NGG NGL00817405023295
SAFElife™CDOA-1144WONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW QBF00816862026511
UScreen®USSCupA-10MOB-300CLIAInstant Technologies, Inc.NFT NFV NFW NFY NGG NGL PTG00817405021215
iScreen™ABTDOAK110701AInstant Technologies, Inc.LCM NFT NFV NFW NFY NGG NGL PTG PTH00817405023479
iScreen™ABTDUAW110701AInstant Technologies, Inc.NFT NFV NFW NFY NGG NGL PTG PTH00817405023271
SAFElife™CDOA-3104A3WONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH00816862026573
SAFElife™CDOA-1085NTWONDFO USA CO., LTD.NFT NFV NFY NGG NGL PTG PTH00816862027341
MedlineMPHD121A3CMEDLINE INDUSTRIES, INC.NFT20193489017530
iScreen™ABTDOAW17701AInstant Technologies, Inc.NFT NFV NFW NFY NGL00817405023332
UScreen®USSCupA-7MOBCLIAInstant Technologies, Inc.NFT NFV NFW NFY NGG NGL00817405021147
T-Cup® Compact ACDOA-1165Instant Technologies, Inc.NFT NFV NFY NGG NGL00817405021000
Prime Screen DTDOA-7125-25BX-AWONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW00816862024746
UScreen®USSCup-5MInstant Technologies, Inc.NFT NFW NFY NGG NGL00817405021161
UScreen®USSCupA-11CLIALCInstant Technologies, Inc.NFT NFV NFW NFY NGG NGL PTG PTH10817405021373
T-Cup® Compact ACDOA-10135Instant Technologies, Inc.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW00817405021024
UScreen®USSCupA-12BUP300CLIAInstant Technologies, Inc.LCM NFT NFV NFW NFY NGG NGL PTG PTH00817405021178
SAFElife™CDOA-1144A3WONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW QBF00816862026535
Prime ScreenDUDOA-1144-5BX-AWONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW QBF00816862024166
Prime ScreenDCDOA-3124-50BX-AWONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW00816862024890
iScreen™ABTDUAW110705EInstant Technologies, Inc.LCM NFT NFV NFY NGG NGL PTG PTH00817405023417
iScreen™ABTDUAW16701AInstant Technologies, Inc.NFT NFV NFW NFY NGL00817405023257
T-Cup CompactCDOA-L6125WONDFO USA CO., LTD.LCM NFT NFV NFW NFY NGG NGL PTG PTH00816862023619