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
K030211Substantially Equivalent

Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016

Icn Biomedicals, Inc., Burlingame CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030211 is the FDA 510(k) clearance record for RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016, a class II device, cleared for Icn Biomedicals, Inc. on under FDA product code DKX (Thin Layer Chromatography, Barbiturate). FDA records list 11 510(k) clearances for Icn Biomedicals, Inc., from to . As of , FDA records show no recalls naming K030211.

Clearance record

Decision date
Received
(143 days to decision)
Product code
DKX Thin Layer Chromatography, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Icn Biomedicals, Inc. 1429 Rollins Rd., Burlingame CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DKX

Trailing 12 months

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

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