ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
FDA 510(k) clearance K992851 · decided 2000-01-14
Clearance details
- K-number
- K992851
- Device name
- ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-24
- Decision date
- 2000-01-14
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (K994194) | Cardiovascular Diagnostics, Inc. | 2000-03-28 |
| I-STAT SYSTEM (K992571) | I-Stat Corp. | 2000-02-10 |
| GBACT + KIT (K984141) | Sienco, Inc. | 1999-05-28 |
| MAX-ACT (K983649) | Array Medical, Inc. | 1998-12-11 |
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Recalls involving this device
No recalls on record reference this clearance.
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