PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT— 510(k) K863625

Name: FDA 510(k) clearance K863625
Creator: U.S. Food and Drug Administration
Published: 1986-11-10

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K863625 for PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT, Substantially Equivalent on 1986-11-10. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code LGQ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1986-09-17
Decision date: 1986-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

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