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FDA 510(k)

ZETAPHASE-DIG

K-Number: K822053 · 1982-07-27

ApplicantBiological & Diagnostic Products
Decision Date1982-07-27
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ZETAPHASE-DIG is the device name listed in this FDA 510(k) record. The listed applicant is Biological & Diagnostic Products. It received FDA 510(k) clearance on 1982-07-27 under 510(k) number K822053. 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 ZETAPHASE-DIG?

ZETAPHASE-DIG is a medical device that received FDA 510(k) clearance on 1982-07-27. The listed applicant is Biological & Diagnostic Products. The 510(k) number is K822053.

When did ZETAPHASE-DIG receive FDA 510(k) clearance?

ZETAPHASE-DIG received FDA 510(k) clearance on 1982-07-27, under 510(k) number K822053.

Who is the listed applicant for ZETAPHASE-DIG?

The FDA 510(k) record lists Biological & Diagnostic Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZETAPHASE-DIG?

The FDA product code for ZETAPHASE-DIG is DON.

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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.K821000ENZYMUNE-TEST DIGOXINIcl ScientificK810296DIGOXIN RIA ASSAYRia Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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