OPUS FERRITIN TEST SYSTEM
FDA 510(k) clearance K915838 · decided 1992-03-18
Clearance details
- K-number
- K915838
- Device name
- OPUS FERRITIN TEST SYSTEM
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-24
- Decision date
- 1992-03-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DGE
- Device class
- 2
- Regulation number
- 866.5510
- 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
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (K871972) | American Dade | 1987-07-21 |
Recalls involving this device
No recalls on record reference this clearance.