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FDA 510(k)

DIGOXIN RIA (PEG) KIT

K-Number: K781335 · 1978-08-31

ApplicantOrtho Diagnostics, Inc.
Decision Date1978-08-31
Product CodeDOG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN RIA (PEG) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781335. 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 DIGOXIN RIA (PEG) KIT?

DIGOXIN RIA (PEG) KIT is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K781335.

When did DIGOXIN RIA (PEG) KIT receive FDA 510(k) clearance?

DIGOXIN RIA (PEG) KIT received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781335.

Who is the listed applicant for DIGOXIN RIA (PEG) KIT?

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

What is the FDA product code for DIGOXIN RIA (PEG) KIT?

The FDA product code for DIGOXIN RIA (PEG) KIT is DOG.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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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 DadeK760709EMIT 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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