510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800537Substantially Equivalent

Gamma Stick Gentamicin Ria Kit

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

K800537 is the FDA 510(k) clearance record for GAMMA STICK GENTAMICIN RIA KIT, a class II device, cleared for Alpha Gamma Laboratory on under FDA product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.). FDA records list 4 510(k) clearances for Alpha Gamma Laboratory, from to . As of , FDA records show no recalls naming K800537.

Clearance record

Decision date
Received
(45 days to decision)
Product code
DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Alpha Gamma Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DJB

Trailing 12 months

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

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