Cleared Traditional

SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (K993983) - FDA 510(k) Clearance

K993983 · Syva Co. · Toxicology device
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Jan 2000
Decision
64d
Days
-
Risk

K993983 is an FDA 510(k) clearance for the SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 64 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 Syva Co. devices

Submission Details

510(k) Number K993983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
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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