510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K994403Substantially Equivalent

Instant-View Cocaine (Benzylecgonine) Urine Dip Strip Test

Alfa Scientific Designs, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994403 is the FDA 510(k) clearance record for INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST, a class II device, cleared for Alfa Scientific Designs, Inc. on under FDA product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites). FDA records list 43 510(k) clearances for Alfa Scientific Designs, Inc., from to . As of , FDA records show no recalls naming K994403.

Clearance record

Decision date
Received
(230 days to decision)
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Alfa Scientific Designs, Inc. 11494 Sorrento Valley Rd.,, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code DIO

Trailing 12 months

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

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