510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820683Substantially Equivalent

Staphylococcus Latex Agglutination Kit

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

K820683 is the FDA 510(k) clearance record for STAPHYLOCOCCUS LATEX AGGLUTINATION KIT, a class I device, cleared for American Scientific Products on under FDA product code LHT (Staphylococcus Aureus Somatic Antigens). FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K820683.

Clearance record

Decision date
Received
(34 days to decision)
Product code
LHT Staphylococcus Aureus Somatic Antigens
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
American Scientific Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHT

Trailing 12 months

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

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