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
K801729Substantially Equivalent

Androstenedione Radioimmunoassay Kit

Diagnostics Biochem Canada, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801729 is the FDA 510(k) clearance record for ANDROSTENEDIONE RADIOIMMUNOASSAY KIT, a class I device, cleared for Diagnostics Biochem Canada, Inc. on under FDA product code CIZ (Radioimmunoassay, Androstenedione). FDA records list 6 510(k) clearances for Diagnostics Biochem Canada, Inc., from to . As of , FDA records show no recalls naming K801729.

Clearance record

Decision date
Received
(99 days to decision)
Product code
CIZ Radioimmunoassay, Androstenedione
Regulation
21 CFR 862.1075
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostics Biochem Canada, Inc. 803 N. Front St. Suite 3, Mchenry IL
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