PHENOBARBITAL ENZYME IMMUNOASSAY— 510(k) K946210

Name: FDA 510(k) clearance K946210
Creator: U.S. Food and Drug Administration
Published: 1995-02-10

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K946210 for PHENOBARBITAL ENZYME IMMUNOASSAY, Substantially Equivalent on 1995-02-10. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1994-12-21
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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