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
K844398Substantially Equivalent

Coat-a-Count Androstenedione Ria Kit

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

K844398 is the FDA 510(k) clearance record for COAT-A-COUNT ANDROSTENEDIONE RIA KIT, a class I device, cleared for Diagnostic Products Corp. on under FDA product code CIZ (Radioimmunoassay, Androstenedione). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K844398.

Clearance record

Decision date
Received
(27 days to decision)
Product code
CIZ Radioimmunoassay, Androstenedione
Regulation
21 CFR 862.1075
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
Third party review
No

Clearances, product code CIZ

Trailing 12 months

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

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