Cleared Traditional

MODIFIED CEDIA DAU PCP ASSAY (K972963) - FDA 510(k) Clearance

K972963 · Boehringer Mannheim Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
42d
Days
-
Risk

K972963 is an FDA 510(k) clearance for the MODIFIED CEDIA DAU PCP ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on September 22, 1997 after a review of 42 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K972963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date September 22, 1997
Days to Decision 42 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
45d faster than avg
Panel avg: 87d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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