510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862395Substantially Equivalent

Biotis Decarboxylase Media, Base

Otisville Biotech, Inc., Otisville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862395 is the FDA 510(k) clearance record for BIOTIS DECARBOXYLASE MEDIA, BASE, a class I device, cleared for Otisville Biotech, Inc. on under FDA product code JSH (Culture Media, Non-Selective And Differential). FDA records list 98 510(k) clearances for Otisville Biotech, Inc., from to . As of , FDA records show no recalls naming K862395.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JSH Culture Media, Non-Selective And Differential
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
Otisville Biotech, Inc. P.O. Box 567, Otisville NY
Third party review
No

Clearances, product code JSH

Trailing 12 months

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

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