Cleared Traditional

K772030 - GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT

K772030 is the FDA 510(k) clearance for GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT by Harleco. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K772030 · Harleco · Chemistry device
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Nov 1977
Decision
18d
Days
Class 1
Risk

K772030 is an FDA 510(k) clearance for the GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 14, 1977 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K772030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1977
Decision Date November 14, 1977
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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 - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 98
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K772030.
STAC SYSTEM
K780373 · Technicon Instruments Corp. · Apr 1978
ULTRAZYME PLUS GPT
K780102 · Harleco · Feb 1978
ALANINE TRANSAMINASE
K780040 · Beckman Instruments, Inc. · Jan 1978
DYNAZYME II GPT 340
K771152 · J.T. Baker Chemical Co. · Nov 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · Instrumentation Laboratory CO · Sep 1977
ULTRAZYME PLUS GPT
K770882 · Harleco · Jul 1977