Cleared Traditional

K921025 - SYNERMED LDHH-L REAGENT KIT

K921025 is the FDA 510(k) clearance for SYNERMED LDHH-L REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K921025 · Synermed, Inc. · Chemistry device
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Mar 1992
Decision
20d
Days
Class 2
Risk

K921025 is an FDA 510(k) clearance for the SYNERMED LDHH-L REAGENT KIT. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on March 23, 1992 after a review of 20 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 Synermed, Inc. devices

Submission Details

510(k) Number K921025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date March 23, 1992
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 85
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K921025.
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K910640 · Em Diagnostic Systems, Inc. · Apr 1991