PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS— 510(k) K935568

Name: FDA 510(k) clearance K935568
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K935568 for PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS, Substantially Equivalent on 1994-03-11. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1993-11-18
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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