Cleared Special

K041578 - QUICKSCREEN

K041578 · Phamatech · Chemistry device
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Sep 2004
Decision
88d
Days
-
Risk

K041578 is an FDA 510(k) clearance for the QUICKSCREEN, MODELS 9177X AND 9178X. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 K041578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date September 10, 2004
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
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