DSL ESTRONE (DSL 8700)
FDA 510(k) clearance K935013 · decided 1994-06-16
Clearance details
- K-number
- K935013
- Device name
- DSL ESTRONE (DSL 8700)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-20
- Decision date
- 1994-06-16
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- CGF
- Device class
- 1
- Regulation number
- 862.1280
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, 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 |
| ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966) | Diagnostics Biochem Canada, Inc. | 1987-01-09 |
| IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (K833406) | Corning Medical & Scientific | 1984-01-24 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Estrone RIA, REF: DSL8700 recall (Z-1369-2026) | Immunotech A.S. | 2026-02-13 |
| Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro dia recall (Z-2336-2025) | Immunotech A.S. | 2025-08-18 |
| Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of recall (Z-2152-2025) | Beckman Coulter Inc. | 2025-07-21 |
| Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use. recall (Z-1685-2011) | Beckman Coulter Inc. | 2011-03-17 |