Cleared Traditional

K833029 - FLOW-PAC GGT REAGENT SET

K833029 is the FDA 510(k) clearance for FLOW-PAC GGT REAGENT SET by American Research Products Co.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K833029 · American Research Products Co. · Chemistry device
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Dec 1983
Decision
113d
Days
Class 1
Risk

K833029 is an FDA 510(k) clearance for the FLOW-PAC GGT REAGENT SET. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by American Research Products Co. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all American Research Products Co. devices

Submission Details

510(k) Number K833029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1983
Decision Date December 29, 1983
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 45
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K833029.
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · Data Medical Associates, Inc. · Dec 1984
SYSTEMATE 2GT - 67207
K843268 · Em Diagnostic Systems, Inc. · Sep 1984
DART GAMMA-GT REAGENT SYSTEM
K834054 · Coulter Electronics, Inc. · Feb 1984
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · American Dade · Oct 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · Emd Chemicals, Inc. · Feb 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · Emd Chemicals, Inc. · Feb 1983