ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
FDA 510(k) clearance K964609 · decided 1997-03-06
Clearance details
- K-number
- K964609
- Device name
- ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
- Applicant
- Array Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-18
- Decision date
- 1997-03-06
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bridgewater, NJ, US
- Third-party review
- No
- Expedited review
- No
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| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528) | Sienco, Inc. | 2000-08-31 |
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| ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851) | Roche Diagnostics Corp. | 2000-01-14 |
| GBACT + KIT (K984141) | Sienco, Inc. | 1999-05-28 |
| MAX-ACT (K983649) | Array Medical, Inc. | 1998-12-11 |
Recalls involving this device
No recalls on record reference this clearance.