ABBOTT AXSYM PROLACTIN(MODIFICATION)— 510(k) K953657

Name: FDA 510(k) clearance K953657
Creator: U.S. Food and Drug Administration
Published: 1995-09-25

Substantially Equivalent

Abbott Mfg., Inc.

FDA 510(k) clearance K953657 for ABBOTT AXSYM PROLACTIN(MODIFICATION), Substantially Equivalent on 1995-09-25. Applicant: Abbott Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Abbott Mfg., Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1995-07-18
Decision date: 1995-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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