510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991698Substantially Equivalent

Redi-Test Pcp

Redwood Biotech, Inc., Mountian View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991698 is the FDA 510(k) clearance record for REDI-TEST PCP, cleared for Redwood Biotech, Inc. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 6 510(k) clearances for Redwood Biotech, Inc., from to . As of , FDA records show no recalls naming K991698.

Clearance record

Decision date
Received
(99 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Redwood Biotech, Inc. 2440 Leghorn St., Mountian View CA
510(k) summary
Summary
Third party review
No

Clearances, product code LCM

Trailing 12 months

FDA records hold no clearances under product code LCM in the trailing twelve months.

FDA records show no clearances under product code LCM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260