Cleared Traditional

K833029 - FLOW-PAC GGT REAGENT SET

K833029 is an FDA 510(k) clearance for FLOW-PAC GGT REAGENT SET, manufactured by American Research Products Co.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K833029

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.

JQB Device Classification - Class 1, General Controls

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 51
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