CLINOVATIVE II DIAGNOSTIC KIT— 510(k) K831837

Name: FDA 510(k) clearance K831837
Creator: U.S. Food and Drug Administration
Published: 1983-08-01

Substantially Equivalent

Pierce Chemical Co.

FDA 510(k) clearance K831837 for CLINOVATIVE II DIAGNOSTIC KIT, Substantially Equivalent on 1983-08-01. Applicant: Pierce Chemical Co.. Device class: 2.

Clearance details

Applicant: Pierce Chemical Co.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1983-06-07
Decision date: 1983-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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