ASSAY, AMPHET. NDC#11711-0127-1 COULTER— 510(k) K760196

Name: FDA 510(k) clearance K760196
Creator: U.S. Food and Drug Administration
Published: 1976-08-03

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K760196 for ASSAY, AMPHET. NDC#11711-0127-1 COULTER, Substantially Equivalent on 1976-08-03. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1976-07-06
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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