STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
FDA 510(k) clearance K871972 · decided 1987-07-21
Clearance details
- K-number
- K871972
- Device name
- STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1987-05-21
- Decision date
- 1987-07-21
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DGE
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| OPUS FERRITIN TEST SYSTEM (K915838) | Pb Diagnostic Systems, Inc. | 1992-03-18 |
Recalls involving this device
No recalls on record reference this clearance.