ACE PHENYTOIN REAGENT, AED CALIBRATORS— 510(k) K973414

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K973414 for ACE PHENYTOIN REAGENT, AED CALIBRATORS, Substantially Equivalent on 1997-11-04. Applicant: Schiapparelli Biosystems, Inc..

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 1997-09-09
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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