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FDA 510(k)

ECLIPSE ICA DIGOXIN

K-Number: K905719 · 1991-01-17

ApplicantBiotope, Inc.
Decision Date1991-01-17
Product CodeDPO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-01-17 under 510(k) number K905719. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE ICA DIGOXIN?

ECLIPSE ICA DIGOXIN is a medical device that received FDA 510(k) clearance on 1991-01-17. The listed applicant is Biotope, Inc.. The 510(k) number is K905719.

When did ECLIPSE ICA DIGOXIN receive FDA 510(k) clearance?

ECLIPSE ICA DIGOXIN received FDA 510(k) clearance on 1991-01-17, under 510(k) number K905719.

Who is the listed applicant for ECLIPSE ICA DIGOXIN?

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

What is the FDA product code for ECLIPSE ICA DIGOXIN?

The FDA product code for ECLIPSE ICA DIGOXIN is DPO.

Related Clinical Trials

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.

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Other records listing Biotope, Inc. 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.

K905145ECLIPSE ICA CHOLESTEROLK910302ECLIPSE ICA ANALYZERK910256ECLIPSE ICA TSHK905601ECLIPSE ICA TRIGLYCERIDESK905602ECLIPSE ICA BUNK905144ECLIPSE ICA GLUCOSE

View all 7 devices →

Related Devices (Code: DPO)

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.

K914833IMMULITE DIGOXINCirrus Diagnostics, Inc.K864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.K833842RIA COAT DIGOXINImmuno Assay Corp.K832163SOPHEIA DIGOXIN EIA KITDiagnostic Products Corp.K830962IMMUCHEM COVALENT-COAT RIA KITImmuchem Corp.K811932COAT-A-COUNT DIGOXIN RIADiagnostic 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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