510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860091Substantially Equivalent

Bio Spec Gramafluor Test Kit

Bio Spec, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860091 is the FDA 510(k) clearance record for BIO SPEC GRAMAFLUOR TEST KIT, a class I device, cleared for Bio Spec, Inc. on under FDA product code JTO (Discs, Strips And Reagents, Microorganism Differentiation). FDA records list 3 510(k) clearances for Bio Spec, Inc., from to . As of , FDA records show no recalls naming K860091.

Clearance record

Decision date
Received
(11 days to decision)
Product code
JTO Discs, Strips And Reagents, Microorganism Differentiation
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Bio Spec, Inc. 179 Mason Cir. #A, Concord CA
Third party review
No

Clearances, product code JTO

Trailing 12 months

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

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