510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834424Substantially Equivalent

Sfp Agar Plates

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

K834424 is the FDA 510(k) clearance record for SFP AGAR PLATES, a class I device, cleared for Otisville Biotech, Inc. on under FDA product code JSJ (Culture Media, Selective And Non-Differential). FDA records list 98 510(k) clearances for Otisville Biotech, Inc., from to . As of , FDA records show no recalls naming K834424.

Clearance record

Decision date
Received
(313 days to decision)
Product code
JSJ Culture Media, Selective And Non-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 JSJ

Trailing 12 months

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

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