Cleared Traditional

K812836 - LDH REAGENT SET (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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Submission Details

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
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.