FDA 510(k) Premarket Notification K832535: HEKTOEN ENTERIC AGAR PLATE

Submission Details & Decision

Normalized public record details for 510(k) notification K832535.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K832535

Applicant / Sponsor

Otisville Biotech, Inc.

Device Name

HEKTOEN ENTERIC AGAR PLATE

Product Code

JSI

Decision Date

1983-10-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-07-29

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