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FDA 510(k)

DCA DIGOX-SYN RIA TEST

K-Number: K810477 · 1981-03-11

ApplicantDiagnostic Corp. of America
Decision Date1981-03-11
Product CodeDOG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DCA DIGOX-SYN RIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Corp. of America. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810477. The device is classified under product code DOG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCA DIGOX-SYN RIA TEST?

DCA DIGOX-SYN RIA TEST is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Diagnostic Corp. of America. The 510(k) number is K810477.

When did DCA DIGOX-SYN RIA TEST receive FDA 510(k) clearance?

DCA DIGOX-SYN RIA TEST received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810477.

Who is the listed applicant for DCA DIGOX-SYN RIA TEST?

The FDA 510(k) record lists Diagnostic Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCA DIGOX-SYN RIA TEST?

The FDA product code for DCA DIGOX-SYN RIA TEST is DOG.

Related Clinical Trials

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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Other records listing Diagnostic Corp. of America 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.

K781150RIA TSH IN HUMAN SERUM OR PLASMAK780412TOTAL IRON BINDING CAPACITY

Related Devices (Code: DOG)

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.

K803045IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.American DadeK781335DIGOXIN RIA (PEG) KITOrtho Diagnostics, Inc.K760709EMIT DIGOKIN ASSAYSyva Co.K760416DATA-TOPE SYSTEM DIGOXIN RIADade, Baxter Travenol Diagnostics, Inc.

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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