OPUS PROGESTERONE
FDA 510(k) clearance K971725 · decided 1997-06-18
Clearance details
- K-number
- K971725
- Device name
- OPUS PROGESTERONE
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-09
- Decision date
- 1997-06-18
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JLS
- Device class
- 1
- Regulation number
- 862.1620
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |