ACE PRIMIDONE REAGENT, AED CALIBRATORS— 510(k) K973582

Name: FDA 510(k) clearance K973582
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K973582 for ACE PRIMIDONE REAGENT, AED CALIBRATORS, Substantially Equivalent on 1997-11-12. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code DJD
Device class: Class 2
Regulation: 21 CFR 862.3680
Advisory panel: Clinical Toxicology
Date received: 1997-09-22
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

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