510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003209Substantially Equivalent

Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. Df93a

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003209 is the FDA 510(k) clearance record for URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A, a class II device, cleared for Dade Behring, Inc. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K003209.

Clearance record

Decision date
Received
(53 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code DJG

Trailing 12 months
3 clearances under product code DJG in the twelve months to November 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DJG, trailing twelve months
MonthClearances
December 20250
January 20263
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260