Cleared Traditional

K883206 - LACTATE DEHYDROGENASE LDH

K883206 is an FDA 510(k) clearance for LACTATE DEHYDROGENASE LDH, manufactured by Electro-Nucleonics, Inc.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K883206 · Electro-Nucleonics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
43d
Days
Class 2
Risk

K883206 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE LDH. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 43 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 Electro-Nucleonics, Inc. devices

FDA 510(k) Submission Details - K883206

510(k) Number K883206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date September 09, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 105
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K883206.
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
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · Abbott Laboratories · Jun 1988
LDH-L REAGENT SET
K880842 · Tech-Neal Scientific, Inc. · Apr 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988