C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)— 510(k) K982442

Name: FDA 510(k) clearance K982442
Creator: U.S. Food and Drug Administration
Published: 1998-08-25

Substantially Equivalent

Care Wise Medical Products Corp.

FDA 510(k) clearance K982442 for C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK), Substantially Equivalent on 1998-08-25. Applicant: Care Wise Medical Products Corp.. Device class: 1.

Clearance details

Applicant: Care Wise Medical Products Corp.
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 1998-07-14
Decision date: 1998-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

Download summary PDF View on FDA.gov ↗

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