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FDA 510(k)

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C

K-Number: K851032 · 1985-04-03

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-04-03
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K851032. 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 COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C?

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K851032.

When did COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C receive FDA 510(k) clearance?

COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C received FDA 510(k) clearance on 1985-04-03, under 510(k) number K851032.

Who is the listed applicant for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C?

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

What is the FDA product code for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C?

The FDA product code for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C is KXT.

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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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