Cleared Traditional

K862392 - BIOTIS MOTILITY TEST MEDIUM
(FDA 510(k) Clearance)

K862392 · Otisville Biotech, Inc. · Microbiology device

Jul 1986

Decision

Days

Class 1

Risk

K862392 is an FDA 510(k) clearance for the BIOTIS MOTILITY TEST MEDIUM. This device is classified as a Culture Media, Single Biochemical Test (Class I - General Controls, product code JSF).

Submitted by Otisville Biotech, Inc. (Otisville, US). The FDA issued a Cleared decision on July 3, 1986, 9 days after receiving the submission on June 24, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number	K862392 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1986
Decision Date	July 03, 1986
Days to Decision	9 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—