510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812188Substantially Equivalent

Cryptococcal Antigen Latex Aggluti

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

K812188 is the FDA 510(k) clearance record for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI, a class II device, cleared for American Scientific Products on under FDA product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans). FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K812188.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
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 GMD

Trailing 12 months

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

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