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FDA 510(k)

DATA-TOPE SYSTEM DIGOXIN RIA

K-Number: K760416 · 1976-08-23

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1976-08-23
Product CodeDOG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DATA-TOPE SYSTEM DIGOXIN RIA is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760416. 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 DATA-TOPE SYSTEM DIGOXIN RIA?

DATA-TOPE SYSTEM DIGOXIN RIA is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K760416.

When did DATA-TOPE SYSTEM DIGOXIN RIA receive FDA 510(k) clearance?

DATA-TOPE SYSTEM DIGOXIN RIA received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760416.

Who is the listed applicant for DATA-TOPE SYSTEM DIGOXIN RIA?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATA-TOPE SYSTEM DIGOXIN RIA?

The FDA product code for DATA-TOPE SYSTEM DIGOXIN RIA is DOG.

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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.

K810477DCA DIGOX-SYN RIA TESTDiagnostic Corp. of AmericaK803045IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.American DadeK781335DIGOXIN RIA (PEG) KITOrtho Diagnostics, Inc.K760709EMIT DIGOKIN ASSAYSyva Co.

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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