510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901371Substantially Equivalent

Aso-Cube(tm)

Difco Laboratories, Inc., Detroit MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901371 is the FDA 510(k) clearance record for ASO-CUBE(TM), a class I device, cleared for Difco Laboratories, Inc. on under FDA product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K901371.

Clearance record

Decision date
Received
(53 days to decision)
Product code
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Regulation
21 CFR 866.3720
Device class
Class I
Review panel
Microbiology
Applicant
Difco Laboratories, Inc. P. O. Box 331058, Detroit MI
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