ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER— 510(k) K973743

Name: FDA 510(k) clearance K973743
Creator: U.S. Food and Drug Administration
Published: 1997-10-31

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973743 for ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, Substantially Equivalent on 1997-10-31. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code CHP
Device class: Class 1
Regulation: 21 CFR 862.1260
Advisory panel: Clinical Chemistry
Date received: 1997-10-01
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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