Cleared Traditional

K943711 - EZ-SCREEN:PCP

K943711 · Editek, Inc. · Toxicology device
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Sep 1994
Decision
39d
Days
-
Risk

K943711 is an FDA 510(k) clearance for the EZ-SCREEN:PCP. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Editek, Inc. (Burlington, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 39 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.

FDA 510(k) Submission Details - K943711

510(k) Number K943711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date September 09, 1994
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K943711.
EMIT IIC PHENCYCLIDINE ASSAY
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K946059 · Microgenics Corp. · Jan 1995
CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
K944605 · Beckman-Diagnostic Systems Group · Dec 1994
USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
K935629 · U.S. Drug Testing, Inc. · Apr 1994
CEDIA(R) DAU PCP ASSAY
K935650 · Microgenics Corp. · Apr 1994
PHENCYCLIDINE EIA ASSAY
K935320 · Diagnostic Reagents, Inc. · Dec 1993
K943711 · EZ-SCREEN:PCP
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