510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812189Substantially Equivalent

Coccidioides Latex Agglutination

American Scientific Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812189 is the FDA 510(k) clearance record for COCCIDIOIDES LATEX AGGLUTINATION, a class II device, cleared for American Scientific Products on under FDA product code GMG (Antigen, Latex Agglutination, Coccidioides Immitis). FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K812189.

Clearance record

Decision date
Received
(22 days to decision)
Product code
GMG Antigen, Latex Agglutination, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
Review panel
Microbiology
Applicant
American Scientific Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GMG

Trailing 12 months

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

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