510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885113Substantially Equivalent

Ifa* Positive and Negative Antigens Control

Investigacion Farmaceutica S.A. de C.V., Mexico, MX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885113 is the FDA 510(k) clearance record for IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL, a class II device, cleared for Investigacion Farmaceutica S.A. DE C.V. on under FDA product code GSN (Antiserum, Positive And Negative Febrile Antigen Control Serum). FDA records list 24 510(k) clearances for Investigacion Farmaceutica S.A. DE C.V., from to . As of , FDA records show no recalls naming K885113.

Clearance record

Decision date
Received
(246 days to decision)
Product code
GSN Antiserum, Positive And Negative Febrile Antigen Control Serum
Regulation
21 CFR 866.3085
Device class
Class II
Review panel
Microbiology
Applicant
Investigacion Farmaceutica S.A. DE C.V. Calle 13-E # 5 Civac, Mexico, MX
Third party review
No

Clearances, product code GSN

Trailing 12 months

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

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