510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851976Substantially Equivalent

Hem Ave-Toxo Screening Hemagglutination Test Kit

Si Sero-Immuno Diagnostics, Inc., Tucker GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851976 is the FDA 510(k) clearance record for HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT, a class II device, cleared for Si Sero-Immuno Diagnostics, Inc. on under FDA product code GMM (Antigens, Iha, Toxoplasma Gondii). FDA records list 2 510(k) clearances for Si Sero-Immuno Diagnostics, Inc. As of , FDA records show no recalls naming K851976.

Clearance record

Decision date
Received
(162 days to decision)
Product code
GMM Antigens, Iha, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Si Sero-Immuno Diagnostics, Inc. P.O. Box 1230, Tucker GA
Third party review
No

Clearances, product code GMM

Trailing 12 months

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

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