Cleared Special

K002776 - MODIFICATION TO PROFILE -II

K002776 · Medtox Diagnostics, Inc. · Toxicology device
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Sep 2000
Decision
22d
Days
-
Risk

K002776 is an FDA 510(k) clearance for the MODIFICATION TO PROFILE -II. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on September 28, 2000 after a review of 22 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.

FDA 510(k) Submission Details - K002776

510(k) Number K002776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2000
Decision Date September 28, 2000
Days to Decision 22 days
Submission Type Special
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
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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K002776 · MODIFICATION TO PROFILE -II
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