510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760097Substantially Equivalent

Febrile Antigens & Control Serums

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

K760097 is the FDA 510(k) clearance record for FEBRILE ANTIGENS & CONTROL SERUMS, a class I device, cleared for Gamma Biologicals, Inc. on under FDA product code GSZ (Antigens, Febrile (Weil-Felix), All Groups). FDA records list 21 510(k) clearances for Gamma Biologicals, Inc., from to . As of , FDA records show no recalls naming K760097.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GSZ Antigens, Febrile (Weil-Felix), All Groups
Regulation
21 CFR 866.3410
Device class
Class I
Review panel
Microbiology
Applicant
Gamma Biologicals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GSZ

Trailing 12 months

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

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