TAS ANALYZER, MODEL 1009— 510(k) K990566
Substantially EquivalentCardiovascular Diagnostics, Inc.
FDA 510(k) clearance K990566 for TAS ANALYZER, MODEL 1009, Substantially Equivalent on 1999-05-14. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Diagnostics, Inc.
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Recent devices under product code JPA
view allMore clearances from Cardiovascular Diagnostics, Inc.
view all- K013305 — ENOXAPARIN TEST CARD
- K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
- K994159 — HMP CONTROLS (TAS) RAPIDPOINT
- K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- K981206 — TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.