MASTERCAP AM 5.0/MASTERCAP RM 5.0— 510(k) K970420

Name: FDA 510(k) clearance K970420
Creator: U.S. Food and Drug Administration
Published: 1997-06-30

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K970420 for MASTERCAP AM 5.0/MASTERCAP RM 5.0, Substantially Equivalent on 1997-06-30. Applicant: Pharmacia, Inc.. Device class: 1.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1997-02-03
Decision date: 1997-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westervillle, OH, US

Download summary PDF View on FDA.gov ↗

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