BEHRING COAGULATION SYSTEM
FDA 510(k) clearance K970431 · decided 1997-05-05
Clearance details
- K-number
- K970431
- Device name
- BEHRING COAGULATION SYSTEM
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-04
- Decision date
- 1997-05-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagu recall (Z-0825-2016) | Siemens Healthcare Diagnostics, Inc. | 2016-02-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |