510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820786Substantially Equivalent

Aso Sure Plus

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

K820786 is the FDA 510(k) clearance record for ASO SURE PLUS, a class I device, cleared for Analytical Products, Inc. on under FDA product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent). FDA records list 57 510(k) clearances for Analytical Products, Inc., from to . As of , FDA records show no recalls naming K820786.

Clearance record

Decision date
Received
(16 days to decision)
Product code
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Analytical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GTQ

Trailing 12 months

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

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