HMP CONTROLS (TAS) RAPIDPOINT— 510(k) K994159

Name: FDA 510(k) clearance K994159
Creator: U.S. Food and Drug Administration
Published: 2000-02-15

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K994159 for HMP CONTROLS (TAS) RAPIDPOINT, Substantially Equivalent on 2000-02-15. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascular Diagnostics, Inc.
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1999-12-09
Decision date: 2000-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST2000-01-14
K990566 — TAS ANALYZER, MODEL 10091999-05-14
K981206 — TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)1998-05-26

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