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FDA 510(k)

ENZYMUNE-TEST DIGOXIN

K-Number: K821000 · 1982-04-26

ApplicantIcl Scientific
Decision Date1982-04-26
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENZYMUNE-TEST DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K821000. 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 ENZYMUNE-TEST DIGOXIN?

ENZYMUNE-TEST DIGOXIN is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Icl Scientific. The 510(k) number is K821000.

When did ENZYMUNE-TEST DIGOXIN receive FDA 510(k) clearance?

ENZYMUNE-TEST DIGOXIN received FDA 510(k) clearance on 1982-04-26, under 510(k) number K821000.

Who is the listed applicant for ENZYMUNE-TEST DIGOXIN?

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

What is the FDA product code for ENZYMUNE-TEST DIGOXIN?

The FDA product code for ENZYMUNE-TEST DIGOXIN is DON.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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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 ProductsK810296DIGOXIN RIA ASSAYRia Diagnostics

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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