Cleared Traditional

K840006 - KINETIC LDH

K840006 is the FDA 510(k) clearance for KINETIC LDH by American Monitor Corp.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K840006 · American Monitor Corp. · Chemistry device
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Mar 1984
Decision
79d
Days
Class 2
Risk

K840006 is an FDA 510(k) clearance for the KINETIC LDH, A< BLUE 610 METHOD. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 79 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 American Monitor Corp. devices

Submission Details

510(k) Number K840006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date March 23, 1984
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K840006.
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · Sigma Diagnostics, Inc. · Jun 1984
TDX REA LDH
K841703 · Abbott Laboratories · Jun 1984
LDH-UV REAGENT SET
K841058 · Medical Specialties, Inc. · May 1984
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048 · Beckman Instruments, Inc. · Jul 1983
RAICHEM LDH-P REAGENT W/SEPARATE START-
K831419 · Reagents Applications, Inc. · Jun 1983
ASTRA SYSTEMS ENZYME MODULE
K831353 · Beckman Instruments, Inc. · Jun 1983