ACE CEDIA PHENOBARBITAL ASSAY— 510(k) K942501

Name: FDA 510(k) clearance K942501
Creator: U.S. Food and Drug Administration
Published: 1994-10-06

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K942501 for ACE CEDIA PHENOBARBITAL ASSAY, Substantially Equivalent on 1994-10-06. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1994-05-24
Decision date: 1994-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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