510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874179Substantially Equivalent

Biotis (Tm) Sabhi (Double Pour)

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

K874179 is the FDA 510(k) clearance record for BIOTIS (TM) SABHI (DOUBLE POUR), a class I device, cleared for Otisville Biopharm, Inc. on under FDA product code KZI (Culture Media, Enriched). FDA records list 8 510(k) clearances for Otisville Biopharm, Inc., from to . As of , FDA records show no recalls naming K874179.

Clearance record

Decision date
Received
(107 days to decision)
Product code
KZI Culture Media, Enriched
Regulation
21 CFR 866.2330
Device class
Class I
Review panel
Microbiology
Applicant
Otisville Biopharm, Inc. P.O. Box 567 Sanatorium Rd., Otisville NY
Third party review
No

Clearances, product code KZI

Trailing 12 months

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

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