Product code JIQ— Clinical Chemistry

FDA has cleared 13 devices under product code JIQ between 1984 and 2014, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20141 clearance
• 20031 clearance
• 19991 clearance
• 19972 clearances
• 19951 clearance
• 19942 clearances
• 19902 clearances
• 19891 clearance
• 19871 clearance
• 19841 clearance

• Wako Chemicals USA, Inc.2 clearances
• Beckman Instruments, Inc.2 clearances
• Synermed, Inc.1 clearance
• Sclavo, Inc.1 clearance
• Roche Diagnostics Operations (Rdo)1 clearance
• Reagents Applications, Inc.1 clearance
• Osborn Group, Inc.1 clearance
• E K Ind., Inc.1 clearance
• Dupont Medical Products1 clearance
• Diagnostic Specialties1 clearance

• K141925 — TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics Operations (Rdo)·2014-12-09
• K013643 — AUSAM TOTAL ALBUMIN ASSAYAusam Biotecthnologies, Inc.·2003-08-14
• K991800 — HEMOCHEK URINE COLLECTION KITOsborn Group, Inc.·1999-09-24
• K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITDiagnostic Specialties·1997-09-02
• K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTBeckman Instruments, Inc.·1997-04-17
• K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORWako Chemicals USA, Inc.·1995-02-07
• K936202 — URINARY ALBUMIN TEST PACKDupont Medical Products·1994-05-09
• K935662 — SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, Inc.·1994-04-26
• K903123 — RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENTReagents Applications, Inc.·1990-09-14
• K902216 — WAKO(TM) MICRO-ALBUMINWako Chemicals USA, Inc.·1990-06-18
• K895883 — BECKMAN MA MICROALBUMIN REAGENT KITBeckman Instruments, Inc.·1989-12-27
• K870516 — ALBUMIN SCREEN TESTSclavo, Inc.·1987-10-20
• K842915 — SULFOSALICYLIC ACID, 3% W/VE K Ind., Inc.·1984-08-10