Cleared Traditional

K792208 - DURAZYME GOT/AST

K792208 is the FDA 510(k) clearance for DURAZYME GOT/AST by American Monitor Corp.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K792208 · American Monitor Corp. · Chemistry device
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Nov 1979
Decision
25d
Days
Class 2
Risk

K792208 is an FDA 510(k) clearance for the DURAZYME GOT/AST. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Monitor Corp. devices

Submission Details

510(k) Number K792208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1979
Decision Date November 27, 1979
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 106
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K792208.
CENTRIFI CHEM AST/SGOT
K800641 · Union Carbide Corp. · Apr 1980
DURAZYME GOT/AST
K800116 · American Monitor Corp. · Feb 1980
ASI REAGENT
K800065 · Gilford Diagnostics · Feb 1980
NADH OXIDATION, AST/SGOT
K791679 · American Monitor Corp. · Sep 1979
PLUS CHEM S.C.E. REAGENT
K791080 · Smithkline Diagnostics, Inc. · Jul 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
K791082 · Smithkline Diagnostics, Inc. · Jul 1979