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FDA 510(k)

TRI-TUBE RIA

K-Number: K840589 · 1984-03-09

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1984-03-09
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRI-TUBE RIA is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-09 under 510(k) number K840589. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-TUBE RIA?

TRI-TUBE RIA is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K840589.

When did TRI-TUBE RIA receive FDA 510(k) clearance?

TRI-TUBE RIA received FDA 510(k) clearance on 1984-03-09, under 510(k) number K840589.

Who is the listed applicant for TRI-TUBE RIA?

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

What is the FDA product code for TRI-TUBE RIA?

The FDA product code for TRI-TUBE RIA is KHQ.

Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK844583TSH-STATK840466NML CORTISOL RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEMK823679NML 6000 CT

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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