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FDA 510(k)

MODIFIED TSH IRMA KIT

K-Number: K883742 · 1989-01-03

ApplicantPacific Biotech, Inc.
Decision Date1989-01-03
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED TSH IRMA 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 1989-01-03 under 510(k) number K883742. 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 MODIFIED TSH IRMA KIT?

MODIFIED TSH IRMA KIT is a medical device that received FDA 510(k) clearance on 1989-01-03. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K883742.

When did MODIFIED TSH IRMA KIT receive FDA 510(k) clearance?

MODIFIED TSH IRMA KIT received FDA 510(k) clearance on 1989-01-03, under 510(k) number K883742.

Who is the listed applicant for MODIFIED TSH IRMA 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 MODIFIED TSH IRMA KIT?

The FDA product code for MODIFIED TSH IRMA KIT is JLW.

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Other records listing Pacific Biotech, Inc. as applicant

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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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