510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870937Substantially Equivalent

Coat-a-Count Methadone Tkmd1

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870937 is the FDA 510(k) clearance record for COAT-A-COUNT METHADONE TKMD1, a class II device, cleared for Diagnostic Products Corp. on under FDA product code DJR (Enzyme Immunoassay, Methadone). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K870937.

Clearance record

Decision date
Received
(10 days to decision)
Product code
DJR Enzyme Immunoassay, Methadone
Regulation
21 CFR 862.3620
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
Third party review
No

Clearances, product code DJR

Trailing 12 months

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

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