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FDA 510(k)

DNASE AGAR W/TOLUDINE BLUE PLATE

K-Number: K840071 · 1984-02-03

ApplicantOtisville Biotech, Inc.
Decision Date1984-02-03
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DNASE AGAR W/TOLUDINE BLUE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K840071. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DNASE AGAR W/TOLUDINE BLUE PLATE?

DNASE AGAR W/TOLUDINE BLUE PLATE is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K840071.

When did DNASE AGAR W/TOLUDINE BLUE PLATE receive FDA 510(k) clearance?

DNASE AGAR W/TOLUDINE BLUE PLATE received FDA 510(k) clearance on 1984-02-03, under 510(k) number K840071.

Who is the listed applicant for DNASE AGAR W/TOLUDINE BLUE PLATE?

The FDA 510(k) record lists Otisville Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNASE AGAR W/TOLUDINE BLUE PLATE?

The FDA product code for DNASE AGAR W/TOLUDINE BLUE PLATE is JSH.

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Other records listing Otisville Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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