BIOTIS (TM) HAEMOPHILUS DUCREYI— 510(k) K874176

Name: FDA 510(k) clearance K874176
Creator: U.S. Food and Drug Administration
Published: 1988-02-05

Substantially Equivalent

Otisville Biopharm, Inc.

FDA 510(k) clearance K874176 for BIOTIS (TM) HAEMOPHILUS DUCREYI, Substantially Equivalent on 1988-02-05. Applicant: Otisville Biopharm, Inc.. Device class: 1.

Clearance details

Applicant: Otisville Biopharm, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1987-10-13
Decision date: 1988-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

Download summary PDF View on FDA.gov ↗

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K881544 — LITTMAN AGAR1988-04-18

More clearances from Otisville Biopharm, Inc.

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K874179 — BIOTIS (TM) SABHI (DOUBLE POUR)1988-01-28
K874174 — BIOTIS (TM) STARCH HYDROLYSIS WITH BCP1987-12-04
K874175 — BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC1987-12-04
K874177 — BIOTIS (TM) BCYE1987-12-04
K874178 — BIOTIS (TM) BCYE SELECTIVE1987-12-04

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.