IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
FDA 510(k) clearance K833406 · decided 1984-01-24
Clearance details
- K-number
- K833406
- Device name
- IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
- Applicant
- Corning Medical & Scientific
- Decision
- Substantially Equivalent
- Date received
- 1983-09-30
- Decision date
- 1984-01-24
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- CGF
- Device class
- 1
- Regulation number
- 862.1280
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DSL ESTRONE-SULFATE RIA (K970915) | Diagnostic Systems Laboratories, Inc. | 1997-05-16 |
| DSL ESTRONE (DSL 8700) (K935013) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 |
| ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966) | Diagnostics Biochem Canada, Inc. | 1987-01-09 |
Recalls involving this device
No recalls on record reference this clearance.