FDA 510(k)

RIA PHASE DIGOXIN

K-Number: K800205 · 1980-03-19

Decision Date1980-03-19

Product CodeDPO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

RIA PHASE 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 1980-03-19 under 510(k) number K800205. 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 RIA PHASE DIGOXIN?

RIA PHASE DIGOXIN is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K800205.

When did RIA PHASE DIGOXIN receive FDA 510(k) clearance?

RIA PHASE DIGOXIN received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800205.

Who is the listed applicant for RIA PHASE 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 RIA PHASE DIGOXIN?

The FDA product code for RIA PHASE DIGOXIN is DPO.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: DPO)

K914833IMMULITE DIGOXINCirrus Diagnostics, Inc.K905719ECLIPSE ICA DIGOXINBiotope, 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.

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.