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

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..

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.