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FDA 510(k)

TSH QUIK RIA KIT

K-Number: K843545 · 1984-10-02

ApplicantPacific Biotech, Inc.
Decision Date1984-10-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH QUIK RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1984-10-02 under 510(k) number K843545. 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 TSH QUIK RIA KIT?

TSH QUIK RIA KIT is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K843545.

When did TSH QUIK RIA KIT receive FDA 510(k) clearance?

TSH QUIK RIA KIT received FDA 510(k) clearance on 1984-10-02, under 510(k) number K843545.

Who is the listed applicant for TSH QUIK RIA KIT?

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

What is the FDA product code for TSH QUIK RIA KIT?

The FDA product code for TSH QUIK RIA KIT is JLW.

Other records listing Pacific Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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