Cleared Traditional

K780634 - SINGLE VIAL 10 SGOT-TRIS

K780634 is an FDA 510(k) clearance for SINGLE VIAL 10 SGOT-TRIS, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code CIT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K780634 · Boehringer Mannheim Corp. · Toxicology device
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May 1978
Decision
31d
Days
Class 2
Risk

K780634 is an FDA 510(k) clearance for the SINGLE VIAL 10 SGOT-TRIS. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on May 18, 1978 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1100 - the FDA toxicology device 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K780634

510(k) Number K780634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 18, 1978
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

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

All 110
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K780634.
SERUM, GLUTAMIC-OXALOACETIC
K790017 · Fisher Scientific Co., LLC · Feb 1979
AST
K781784 · Gilford Diagnostics · Jan 1979
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725 · Medical Analysis Systems, Inc. · Nov 1978
AST(GOT) UNI-UV, SGOT
K780463 · Sclavo, Inc. · May 1978
SGOT/AST REAGENT SYSTEM
K780443 · American Monitor Corp. · Apr 1978
ULTRAZYME PLUS GOT
K780103 · Harleco · Feb 1978