510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210327Substantially Equivalent

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

WHPM Inc., Irwindale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210327 is the FDA 510(k) clearance record for First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup, a class II device, cleared for W.H.P.M., Inc. on under FDA product code QBF (Test, Propoxyphene, Over The Counter). FDA's definition for product code QBF reads: "The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information...". FDA records list 8 510(k) clearances for W.H.P.M., Inc., from to . As of , FDA records show no recalls naming K210327.

Clearance record

Decision date
Received
(189 days to decision)
Product code
QBF Test, Propoxyphene, Over The Counter
Regulation
21 CFR 862.3700
Device class
Class II
Review panel
Clinical Toxicology
Applicant
W.H.P.M., Inc. 5358 Irwindale Ave., Irwindale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBF

Trailing 12 months

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

FDA records show no clearances under product code QBF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBF, 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