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FDA 510(k)

NOVAPATH TSH ENZYME IMMUNOASSAY

K-Number: K903311 · 1990-09-07

ApplicantBio-Rad
Decision Date1990-09-07
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVAPATH TSH ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K903311. 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 NOVAPATH TSH ENZYME IMMUNOASSAY?

NOVAPATH TSH ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Bio-Rad. The 510(k) number is K903311.

When did NOVAPATH TSH ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

NOVAPATH TSH ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1990-09-07, under 510(k) number K903311.

Who is the listed applicant for NOVAPATH TSH ENZYME IMMUNOASSAY?

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 NOVAPATH TSH ENZYME IMMUNOASSAY?

The FDA product code for NOVAPATH TSH ENZYME IMMUNOASSAY 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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