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FDA 510(k)

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA

K-Number: K772422 · 1978-02-13

ApplicantBio-Rad
Decision Date1978-02-13
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K772422. The device is classified under product code DON. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA?

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is Bio-Rad. The 510(k) number is K772422.

When did QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA receive FDA 510(k) clearance?

QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA received FDA 510(k) clearance on 1978-02-13, under 510(k) number K772422.

Who is the listed applicant for QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA?

The FDA product code for QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA is DON.

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Other records listing Bio-Rad as applicant

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Related Devices (Code: DON)

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.

K902861CIBA CORNING ACS DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K881679CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K840461MAGIC 125I DIGOXIN RADIOIMMUNOASSAYCorning Medical & ScientificK830533PHASE II DIGOXIN RADIOIMMUNOASSAY KITMedical & Scientific Designs, Inc.K822053ZETAPHASE-DIGBiological & Diagnostic ProductsK821000ENZYMUNE-TEST DIGOXINIcl Scientific

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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