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FDA 510(k)

DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

K-Number: K864333 · 1987-01-05

ApplicantWindsor Laboratories, Inc.
Decision Date1987-01-05
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864333. 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 DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY?

DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K864333.

When did DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY receive FDA 510(k) clearance?

DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864333.

Who is the listed applicant for DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY?

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

What is the FDA product code for DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY?

The FDA product code for DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY is KXT.

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Other records listing Windsor Laboratories, 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK870389DIGOXIN (FPIA) CALIBRATOR KITK863625PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

View all 19 devices →

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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