PATHROMTIN SL
FDA 510(k) clearance K955450 · decided 1996-04-19
Clearance details
- K-number
- K955450
- Device name
- PATHROMTIN SL
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1996-04-19
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GFO
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 1 recall (Z-0773-04) | Dade Behring , Inc. | 2004-07-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |