Cleared Traditional

K964912 - LACTATE DEHYDROGENASE

K964912 is an FDA 510(k) clearance for LACTATE DEHYDROGENASE, manufactured by Derma Media Lab., Inc.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K964912 · Derma Media Lab., Inc. · Chemistry device
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Jan 1997
Decision
31d
Days
Class 2
Risk

K964912 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 31 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K964912

510(k) Number K964912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date January 09, 1997
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFJ Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K964912.
LIQUID LDH-L REAGENT SET
K973589 · Pointe Scientific, Inc., · Oct 1997
LACTATE DEHYDROGENASE (LD)
K970684 · Randox Laboratories, Ltd. · May 1997
LD-L REAGENT
K971398 · Carolina Liquid Chemistries Corp. · May 1997
LACTATE DEHYDROGENASE REAGENT SET
K961431 · Pointe Scientific, Inc., · Jun 1996
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · Medical Diagnostic Technologies, Inc. · Aug 1995
HICHEM LDH/L REAGENT KIT
K946022 · Hichem Diagnostics · Feb 1995