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FDA 510(k)

UNISTIK

K-Number: K920562 · 1992-03-27

ApplicantUlster Scientific, Inc.
Decision Date1992-03-27
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNISTIK is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1992-03-27 under 510(k) number K920562. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTIK?

UNISTIK is a medical device that received FDA 510(k) clearance on 1992-03-27. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K920562.

When did UNISTIK receive FDA 510(k) clearance?

UNISTIK received FDA 510(k) clearance on 1992-03-27, under 510(k) number K920562.

Who is the listed applicant for UNISTIK?

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

What is the FDA product code for UNISTIK?

The FDA product code for UNISTIK is FMK.

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Related Devices (Code: FMK)

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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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