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FDA 510(k)

DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY

K-Number: K760883 · 1976-11-19

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1976-11-19
Product CodeDPB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY 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 1976-11-19 under 510(k) number K760883. The device is classified under product code DPB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY?

DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K760883.

When did DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY receive FDA 510(k) clearance?

DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760883.

Who is the listed applicant for DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY?

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 DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY?

The FDA product code for DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY is DPB.

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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 RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEM

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Related Devices (Code: DPB)

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.

K853021OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.K823014DIGOXIN KITPcl-Ria, Inc.K821811125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical TechnologyK820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.K790602RIA, DIGNXIN-125-IEndocrine-Metabolic Center

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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