510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800538Substantially Equivalent

Gamma Stick Cortisol Ria Kit/stick Kit

Alpha Gamma Laboratory, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800538 is the FDA 510(k) clearance record for GAMMA STICK CORTISOL RIA KIT/STICK KIT, a class II device, cleared for Alpha Gamma Laboratory on under FDA product code CGR (Radioimmunoassay, Cortisol). FDA records list 4 510(k) clearances for Alpha Gamma Laboratory, from to . As of , FDA records show no recalls naming K800538.

Clearance record

Decision date
Received
(45 days to decision)
Product code
CGR Radioimmunoassay, Cortisol
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alpha Gamma Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGR

Trailing 12 months

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

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