Cleared Traditional

K935650 - CEDIA DAU PCP ASSAY

K935650 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
133d
Days
-
Risk

K935650 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 April 5, 1994 after a review of 133 days - within the typical 510(k) review window.

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

View all Microgenics Corp. devices

Submission Details

510(k) Number K935650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1993
Decision Date April 05, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 87d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
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CEDIA(R) DAU PCP ASSAY
K946059 · Microgenics Corp. · Jan 1995
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K935320 · Diagnostic Reagents, Inc. · Dec 1993
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