Cleared Traditional

K911153 - MICROZYME PHENCYCLIDINE ENZYME IMMUNOAS...

K911153 · Immunotech Corp. · Toxicology device
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Jun 1991
Decision
95d
Days
-
Risk

K911153 is an FDA 510(k) clearance for the MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on June 18, 1991 after a review of 95 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 Immunotech Corp. devices

Submission Details

510(k) Number K911153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date June 18, 1991
Days to Decision 95 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 87d · This submission: 95d
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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