ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS— 510(k) K973535

Name: FDA 510(k) clearance K973535
Creator: U.S. Food and Drug Administration
Published: 1997-10-20

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K973535 for ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS, Substantially Equivalent on 1997-10-20. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1997-09-18
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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