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FDA 510(k)

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT

K-Number: K802461 · 1980-10-31

ApplicantImmunotech Corp.
Decision Date1980-10-31
Product CodeLCW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802461. The device is classified under product code LCW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT?

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Immunotech Corp.. The 510(k) number is K802461.

When did ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802461.

Who is the listed applicant for ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT?

The FDA product code for ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT is LCW.

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Related Devices (Code: LCW)

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.

K834080MATCHED COMPONENT SET FOR DIGITOXINCambridge Medical TechnologyK780766(125 I) DIGITOXIN RIA KITDiagnostic Products Corp.

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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