K842400Substantially Equivalent

Biotis N.y.c. Carbohydrate Fermenta-

Name: K842400 Biotis N.y.c. Carbohydrate Fermenta-
Creator: Otisville Biotech, Inc.
Published: 1984-07-02
License: https://open.fda.gov/license/

Otisville Biotech, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K842400 is the FDA 510(k) clearance record for BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-, cleared for Otisville Biotech, Inc. on 1984-07-02. FDA records list 98 510(k) clearances for Otisville Biotech, Inc., from 1983-09-29 to 1986-07-03. As of 2026-09-10, FDA records show no recalls naming K842400.

Clearance record

Decision date: 1984-07-02
Received: 1984-06-19 (13 days to decision)
Review panel: Unknown
Applicant: Otisville Biotech, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No