ANTICONVULSANT CONTROL SERUM— 510(k) K760730

Name: FDA 510(k) clearance K760730
Creator: U.S. Food and Drug Administration
Published: 1976-10-07

Substantially Equivalent

Bio-Reagents & Diagnostics, Inc.

FDA 510(k) clearance K760730 for ANTICONVULSANT CONTROL SERUM, Substantially Equivalent on 1976-10-07. Applicant: Bio-Reagents & Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Reagents & Diagnostics, Inc.
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1976-09-27
Decision date: 1976-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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