510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JGQClass II

Turbidimetric, Total Protein

21 CFR 862.1635 / Clinical Chemistry
FDA source (opens on fda.gov)

JGQ is the FDA product code for Turbidimetric, Total Protein, a class II device type, regulated under 21 CFR 862.1635. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JGQ
Device name
Turbidimetric, Total Protein
Regulation
21 CFR 862.1635
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
1

Clearances, product code JGQ

By decision year
13 clearances under product code JGQ with a decision year between 1978 and 2013, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JGQ by decision year
YearClearances
19781
19821
19841
19861
19902
19911
19931
19982
20072
20131

Applicants with the most clearances

Product code JGQ
Applicants holding the most 510(k) clearances under product code JGQ
ApplicantClearances
Abbott Medical2
Em Diagnostic Systems, Inc.2
Roche Diagnostics GmbH2
Baxter Healthcare Corporation1
Boehringer Mannheim Corp.1
E.I. Dupont de Nemours & Co., Inc.1
Canon Medical Diagnostics USA, Inc.1
Somas Medical Industries, Inc.1
Stanbio Laboratory1
Trace America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code