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FDA 510(k)

OPUS(TM) DIGOXIN TEST SYSTEM

K-Number: K901547 · 1990-06-26

ApplicantPb Diagnostic Systems, Inc.
Decision Date1990-06-26
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPUS(TM) DIGOXIN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K901547. 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 OPUS(TM) DIGOXIN TEST SYSTEM?

OPUS(TM) DIGOXIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K901547.

When did OPUS(TM) DIGOXIN TEST SYSTEM receive FDA 510(k) clearance?

OPUS(TM) DIGOXIN TEST SYSTEM received FDA 510(k) clearance on 1990-06-26, under 510(k) number K901547.

Who is the listed applicant for OPUS(TM) DIGOXIN TEST SYSTEM?

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

What is the FDA product code for OPUS(TM) DIGOXIN TEST SYSTEM?

The FDA product code for OPUS(TM) DIGOXIN TEST SYSTEM is KXT.

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Other records listing Pb Diagnostic Systems, 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.

K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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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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