Product code JGQ— Clinical Chemistry

FDA has cleared 13 devices under product code JGQ between 1978 and 2013, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20131 clearance
• 20072 clearances
• 19982 clearances
• 19931 clearance
• 19911 clearance
• 19902 clearances
• 19861 clearance
• 19841 clearance
• 19821 clearance
• 19781 clearance

• Em Diagnostic Systems, Inc.2 clearances
• Abbott Laboratories2 clearances
• Trace America, Inc.1 clearance
• Stanbio Laboratory1 clearance
• Somas Medical Industries, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Roche Diagnostics1 clearance
• Hitachi Chemical Diagnostics, Inc.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Boehringer Mannheim Corp.1 clearance

• K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.·2013-06-07
• K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.·2007-10-19
• K071239 — TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics·2007-09-14
• K981295 — UPROAbbott Laboratories·1998-10-01
• K981682 — UPROAbbott Laboratories·1998-09-21
• K925794 — TRACE MICROPROTEIN REAGENTTrace America, Inc.·1993-03-29
• K913615 — URINARY/CSF PROTEINBoehringer Mannheim Corp.·1991-09-13
• K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANKBaxter Healthcare Corp·1990-10-03
• K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95Em Diagnostic Systems, Inc.·1990-04-16
• K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95Em Diagnostic Systems, Inc.·1986-10-29
• K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAYSomas Medical Industries, Inc.·1984-07-06
• K822231 — ACA URINARY PROTEIN ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1982-09-30
• K780110 — CSF TOTAL PROTEIN TEST SET #0340Stanbio Laboratory·1978-03-03