Cleared Special

AT WORK DRUG TEST, MODEL 9145-25C (K994093) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL 9177-25C
K994093 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
13d
Days
-
Risk

K994093 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9145-25C. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Phamatech devices

Submission Details

510(k) Number K994093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date December 16, 1999
Days to Decision 13 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 87d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

All 10
Devices cleared under the same product code (LCL) and FDA review panel - the closest regulatory comparables to K994093.
ABUSCREEN FP FOR PHENCYCLIDINE
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EMIT HVA PHENCYCLIDINE ASSAY
K882179 · Syva Co. · Jul 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · Abbott Laboratories · Feb 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
K874626 · Syva Co. · Jan 1988
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · Abbott Laboratories · Nov 1987