510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834420Substantially Equivalent

Mannitol-Salt Agar Usp Plate

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

K834420 is the FDA 510(k) clearance record for MANNITOL-SALT AGAR USP PLATE, a class I device, cleared for Otisville Biotech, Inc. on under FDA product code JSI (Culture Media, Selective And Differential). FDA records list 98 510(k) clearances for Otisville Biotech, Inc., from to . As of , FDA records show no recalls naming K834420.

Clearance record

Decision date
Received
(313 days to decision)
Product code
JSI Culture Media, Selective And Differential
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Applicant
Otisville Biotech, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JSI

Trailing 12 months

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

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