ACE(TM) CEDIA(R) PHENYTOIN ASSAY— 510(k) K944085

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K944085 for ACE(TM) CEDIA(R) PHENYTOIN ASSAY, Substantially Equivalent on 1994-12-28. Applicant: Schiapparelli Biosystems, Inc..

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 1994-08-22
Decision date: 1994-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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