Cleared Traditional

K897164 - COULTER LD (LDH-L) REAGENT

K897164 is the FDA 510(k) clearance for COULTER LD (LDH-L) REAGENT by Coulter Electronics, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K897164 · Coulter Electronics, Inc. · Chemistry device
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Mar 1990
Decision
71d
Days
Class 2
Risk

K897164 is an FDA 510(k) clearance for the COULTER LD (LDH-L) REAGENT. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 71 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K897164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date March 09, 1990
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 82
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K897164.
SYNERMED LDH REAGENT KIT
K903773 · Synermed, Inc. · Oct 1990
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667 · American Research Products Co. · Apr 1990
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 1990
COBAS READY LDH REAGENT
K896241 · Roche Diagnostic Systems, Inc. · Feb 1990
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482 · Em Diagnostic Systems, Inc. · Sep 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · Em Diagnostic Systems, Inc. · Nov 1988