Cleared Traditional

REDI-TEST PCP (K991698) - FDA 510(k) Clearance

K991698 · Redwood Biotech, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
99d
Days
-
Risk

K991698 is an FDA 510(k) clearance for the REDI-TEST PCP. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Redwood Biotech, Inc. (Mountian View, US). The FDA issued a Cleared decision on August 25, 1999 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Redwood Biotech, Inc. devices

Submission Details

510(k) Number K991698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date August 25, 1999
Days to Decision 99 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 87d · This submission: 99d
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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