OPUS PSA TEST SYSTEM
FDA 510(k) clearance K964595 · decided 1997-06-24
Clearance details
- K-number
- K964595
- Device name
- OPUS PSA TEST SYSTEM
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-18
- Decision date
- 1997-06-24
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- LTJ
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |