LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM— 510(k) K041349

Name: FDA 510(k) clearance K041349
Creator: U.S. Food and Drug Administration
Published: 2004-09-24

Substantially Equivalent

Ibl GmbH

FDA 510(k) clearance K041349 for LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM, Substantially Equivalent on 2004-09-24. Applicant: Ibl GmbH. Device class: 1.

Clearance details

Applicant: Ibl GmbH
Product code: Code CHP
Device class: Class 1
Regulation: 21 CFR 862.1260
Advisory panel: Clinical Chemistry
Date received: 2004-05-20
Decision date: 2004-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER1997-10-31
K970386 — ACS ESTADIOL-6 II1997-06-04
K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)1997-03-18
K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)1997-02-25

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