DeviceClearance

TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)— 510(k) K981206

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K981206 for TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS), Substantially Equivalent on 1998-05-26. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Cardiovascular Diagnostics, Inc.
Product code
Code GKP
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raleigh, NC, US
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