Cleared Traditional

K831419 - RAICHEM LDH-P REAGENT W/SEPARATE START-

K831419 is the FDA 510(k) clearance for RAICHEM LDH-P REAGENT W/SEPARATE START- by Reagents Applications, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K831419 · Reagents Applications, Inc. · Chemistry device
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Jun 1983
Decision
44d
Days
Class 2
Risk

K831419 is an FDA 510(k) clearance for the RAICHEM LDH-P REAGENT W/SEPARATE START-. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 44 days - a notably fast clearance cycle.

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: 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K831419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1983
Decision Date June 16, 1983
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFJ Nad Reduction/nadh Oxidation, 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 - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 83
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