ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM— 510(k) K992851

Name: FDA 510(k) clearance K992851
Creator: U.S. Food and Drug Administration
Published: 2000-01-14

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K992851 for ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM, Substantially Equivalent on 2000-01-14. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 1999-08-24
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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