Cleared Traditional

K812836 - LDH REAGENT SET

K812836 is an FDA 510(k) clearance for LDH REAGENT SET, manufactured by Anco Medical Reagents & Assoc.. The device is a Class 2 Chemistry device with product code CFH cleared through the Traditional 510(k) pathway .

K812836 · Anco Medical Reagents & Assoc. · Chemistry device
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Oct 1981
Decision
-
Days
Class 2
Risk

K812836 is an FDA 510(k) clearance for the LDH REAGENT SET. Classified as Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (product code CFH), Class II - Special Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1981.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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 Anco Medical Reagents & Assoc. devices

FDA 510(k) Submission Details - K812836

510(k) Number K812836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received October 09, 1981
Decision Date October 09, 1981
Days to Decision -
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFH Device Classification - Class 2, Special Controls

Product Code CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

All 11
Devices cleared under the same product code (CFH) and FDA review panel - the closest regulatory comparables to K812836.
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · Sterling Diagnostics, Inc. · Feb 1986
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · Helena Laboratories · Oct 1985
WAKO LDH CII TEST
K842452 · Wako Chemicals USA, Inc. · Aug 1984
HYCEL LDH-INT TEST
K782176 · Hycel, Inc. · Jan 1979
LDH-INT TEST
K771343 · Hycel, Inc. · Aug 1977
COLORIMETRIC DETERMINATION (LDH)
K760009 · The Dow Chemical Co. · Jul 1976