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FDA 510(k)

THE BIO-TEK UW-II

K-Number: K862932 · 1986-09-25

ApplicantBio-Tek Instruments, Inc.
Decision Date1986-09-25
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE BIO-TEK UW-II is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1986-09-25 under 510(k) number K862932. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BIO-TEK UW-II?

THE BIO-TEK UW-II is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K862932.

When did THE BIO-TEK UW-II receive FDA 510(k) clearance?

THE BIO-TEK UW-II received FDA 510(k) clearance on 1986-09-25, under 510(k) number K862932.

Who is the listed applicant for THE BIO-TEK UW-II?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE BIO-TEK UW-II?

The FDA product code for THE BIO-TEK UW-II is IMJ.

Other records listing Bio-Tek Instruments, Inc. as applicant

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Related Devices (Code: IMJ)

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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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