Cleared Traditional

K821201 - LDH-UV REAGENT SET

K821201 is the FDA 510(k) clearance for LDH-UV REAGENT SET by Omega Medical Electronics. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K821201 · Omega Medical Electronics · Chemistry device
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Jul 1982
Decision
84d
Days
Class 2
Risk

K821201 is an FDA 510(k) clearance for the LDH-UV REAGENT SET. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982 after a review of 84 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 Omega Medical Electronics devices

Submission Details

510(k) Number K821201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date July 20, 1982
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
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 87
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K821201.
ASTRA SYSTEMS ENZYME MODULE
K831353 · Beckman Instruments, Inc. · Jun 1983
FLOW-PAC LDH REAGENT SET
K823721 · Amresco, Inc. · Jan 1983
RAICHEM LDH-L REAGENT
K822312 · Reagents Applications, Inc. · Aug 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466 · Emd Chemicals, Inc. · Jun 1982
LD-L TRIS SYSTEM PACK TEST
K820378 · Boehringer Mannheim Corp. · Mar 1982
LDH-L
K813496 · Pointe Scientific, Inc., · Dec 1981