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FDA 510(k)

ENZYMUN TEST(R) DIGOXIN

K-Number: K901216 · 1990-05-31

ApplicantBoehringer Mannheim Corp.
Decision Date1990-05-31
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENZYMUN TEST(R) DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1990-05-31 under 510(k) number K901216. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMUN TEST(R) DIGOXIN?

ENZYMUN TEST(R) DIGOXIN is a medical device that received FDA 510(k) clearance on 1990-05-31. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K901216.

When did ENZYMUN TEST(R) DIGOXIN receive FDA 510(k) clearance?

ENZYMUN TEST(R) DIGOXIN received FDA 510(k) clearance on 1990-05-31, under 510(k) number K901216.

Who is the listed applicant for ENZYMUN TEST(R) DIGOXIN?

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

What is the FDA product code for ENZYMUN TEST(R) DIGOXIN?

The FDA product code for ENZYMUN TEST(R) DIGOXIN is KXT.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: KXT)

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.

K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche DiagnosticsK102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare DiagnosticsK082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.K061249AXSYM DIGOXIN IIIAbbott Laboratories

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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