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FDA 510(k)

SRI DIGOXIN ENZYME IMMUNOASSAY

K-Number: K915602 · 1992-01-17

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1992-01-17
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SRI DIGOXIN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-01-17 under 510(k) number K915602. 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 SRI DIGOXIN ENZYME IMMUNOASSAY?

SRI DIGOXIN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1992-01-17. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K915602.

When did SRI DIGOXIN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

SRI DIGOXIN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1992-01-17, under 510(k) number K915602.

Who is the listed applicant for SRI DIGOXIN ENZYME IMMUNOASSAY?

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

What is the FDA product code for SRI DIGOXIN ENZYME IMMUNOASSAY?

The FDA product code for SRI DIGOXIN ENZYME IMMUNOASSAY is KXT.

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Other records listing Serono-Baker Diagnostics, 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.

K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

View all 23 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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