FDA 510(k) Premarket Notification K862389: BIOTIS ACETAMIDE AGAR

Submission Details & Decision

Normalized public record details for 510(k) notification K862389.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K862389

Applicant / Sponsor

Otisville Biotech, Inc.

Device Name

BIOTIS ACETAMIDE AGAR

Product Code

JSI

Decision Date

1986-07-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1986-06-24

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.