510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860559Substantially Equivalent

Androstenedione 125I Kit by Ria

Immuchem Corp., Carson CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860559 is the FDA 510(k) clearance record for ANDROSTENEDIONE 125I KIT BY RIA, a class I device, cleared for Immuchem Corp. on under FDA product code CIZ (Radioimmunoassay, Androstenedione). FDA records list 18 510(k) clearances for Immuchem Corp., from to . As of , FDA records show no recalls naming K860559.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CIZ Radioimmunoassay, Androstenedione
Regulation
21 CFR 862.1075
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immuchem Corp. P.O. Box 6227, Carson 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