ACE IRON REAGENT— 510(k) K944911

Name: FDA 510(k) clearance K944911
Creator: U.S. Food and Drug Administration
Published: 1995-02-10

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K944911 for ACE IRON REAGENT, Substantially Equivalent on 1995-02-10. Applicant: Schiapparelli Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1994-10-05
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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