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FDA 510(k)

COTUBE(TM) TSH IRMA

K-Number: K890802 · 1989-03-28

ApplicantBio-Rad
Decision Date1989-03-28
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COTUBE(TM) TSH IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K890802. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTUBE(TM) TSH IRMA?

COTUBE(TM) TSH IRMA is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Bio-Rad. The 510(k) number is K890802.

When did COTUBE(TM) TSH IRMA receive FDA 510(k) clearance?

COTUBE(TM) TSH IRMA received FDA 510(k) clearance on 1989-03-28, under 510(k) number K890802.

Who is the listed applicant for COTUBE(TM) TSH IRMA?

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

What is the FDA product code for COTUBE(TM) TSH IRMA?

The FDA product code for COTUBE(TM) TSH IRMA is JLW.

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Related Devices (Code: JLW)

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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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