FDA 510(k)

ZYME B

K-Number: K820209 · 1982-02-12

Decision Date1982-02-12

Product CodeJTO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ZYME B is the device name listed in this FDA 510(k) record. The listed applicant is Dms Laboratories. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820209. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYME B?

ZYME B is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Dms Laboratories. The 510(k) number is K820209.

When did ZYME B receive FDA 510(k) clearance?

ZYME B received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820209.

Who is the listed applicant for ZYME B?

The FDA 510(k) record lists Dms Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZYME B?

The FDA product code for ZYME B is JTO.

Other records listing Dms Laboratories as applicant

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K831187TRP K831186RAPID NFT K830437CHS K823102AGAR P K821038FAST VIOLET B K813613RAPID CH

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Official Source

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