Cleared Traditional

LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE (K864360) - FDA 510(k) Clearance

K864360 · Trace Scientific , Ltd. · Chemistry device
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Feb 1987
Decision
95d
Days
-
Risk

K864360 is an FDA 510(k) clearance for the LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on February 6, 1987 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K864360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date February 06, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -