Cleared Traditional

K946059 - CEDIA(R) DAU PCP ASSAY (FDA 510(k) Clearance)

K946059 · Microgenics Corp. · Toxicology device
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Jan 1995
Decision
36d
Days
-
Risk

K946059 is an FDA 510(k) clearance for the CEDIA(R) DAU PCP ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology 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: 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 Microgenics Corp. devices

Submission Details

510(k) Number K946059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date January 17, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
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