Cleared Traditional

K760412 - LDH SUBSTRATE

K760412 is the FDA 510(k) clearance for LDH SUBSTRATE by J.T. Baker Chemical Co.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K760412 · J.T. Baker Chemical Co. · Chemistry device
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Nov 1976
Decision
85d
Days
Class 2
Risk

K760412 is an FDA 510(k) clearance for the LDH SUBSTRATE. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976 after a review of 85 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 J.T. Baker Chemical Co. devices

Submission Details

510(k) Number K760412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1976
Decision Date November 02, 1976
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 K760412.
ULTRAZYME PLUS, LDH
K770818 · Harleco · Jul 1977
LDH-L TEST
K770267 · Sclavo, Inc. · Feb 1977
DYNAZYME-II TM LDH-L 340 KIT
K761343 · J.T. Baker Chemical Co. · Jan 1977
AMP BUFFER
K760410 · J.T. Baker Chemical Co. · Oct 1976
NAD (SPOONPAK CONTAINER)
K760411 · J.T. Baker Chemical Co. · Oct 1976