JGQ · Class II · 21 CFR 862.1635

FDA Product Code JGQ: Turbidimetric, Total Protein

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Roche Diagnostics.

13
Total
13
Cleared
74d
Avg days
1978
Since

FDA 510(k) Cleared Turbidimetric, Total Protein Devices (Product Code JGQ)

13 devices
1–13 of 13
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239
Roche Diagnostics
Chemistry · 134d
Cleared Oct 01, 1998
UPRO
K981295
Abbott Laboratories
Chemistry · 175d
Cleared Sep 21, 1998
UPRO
K981682
Abbott Laboratories
Chemistry · 131d
Cleared Sep 13, 1991
URINARY/CSF PROTEIN
K913615
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Oct 03, 1990
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914
Baxter Healthcare Corp
Chemistry · 40d
Cleared Apr 16, 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 30, 1982
ACA URINARY PROTEIN ANALYTICAL TEST PACK
K822231
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 65d
Cleared Mar 03, 1978
CSF TOTAL PROTEIN TEST SET #0340
K780110
Stanbio Laboratory
Chemistry · 43d

About Product Code JGQ - Regulatory Context