Cleared Traditional

K772029 - GEMSAEC APPLI

K772029 is the FDA 510(k) clearance for GEMSAEC APPLI by Harleco. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K772029 · Harleco · Chemistry device
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Nov 1977
Decision
19d
Days
Class 2
Risk

K772029 is an FDA 510(k) clearance for the GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 15, 1977 after a review of 19 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 Harleco devices

Submission Details

510(k) Number K772029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1977
Decision Date November 15, 1977
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 105
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K772029.
SGOT/AST REAGENT SYSTEM
K780443 · American Monitor Corp. · Apr 1978
ULTRAZYME PLUS GOT
K780103 · Harleco · Feb 1978
ASPARTATE TRANSAMINASE
K780039 · Beckman Instruments, Inc. · Jan 1978
DYNA ZYME II GOT 340
K771153 · J.T. Baker Chemical Co. · Nov 1977
NDC#12739-0011-1 C-ZYME GOT
K760193 · Coulter Electronics, Inc. · Aug 1976