Cleared Traditional

EZ-SCREEN PROFILE (K963233) - FDA 510(k) Clearance

K963233 · Editek, Inc. · Toxicology device
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Oct 1996
Decision
73d
Days
-
Risk

K963233 is an FDA 510(k) clearance for the EZ-SCREEN PROFILE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Editek, Inc. (Burlington, US). The FDA issued a Cleared decision on October 31, 1996 after a review of 73 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 Editek, Inc. devices

Submission Details

510(k) Number K963233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date October 31, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 87d · This submission: 73d
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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