PHENOBARBITAL REAGENT TEST KIT— 510(k) K802039

Name: FDA 510(k) clearance K802039
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K802039 for PHENOBARBITAL REAGENT TEST KIT, Substantially Equivalent on 1980-10-23. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1980-08-25
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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