510(k) K970915
- Device
- DSL ESTRONE-SULFATE RIA
- Applicant
- DIAGNOSTIC SYSTEMS LABORATORIES, INC.
- 510(k) number
- K970915
- Product code
- CGF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-16
- Date received
- 1997-03-12
- Regulation
- 862.1280
- Classification name
- Radioimmunoassay, Estrone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN WILLIS
- Address
- 445 Medical Center Blvd. Webster TX US 77598 77598
FDA Registration Numbers#
- 3009335633
- 3002800697
- 3007361513
- 2020726
- 1222302
- 2133982
- 2245285
- 3022178699
- 3007118747
- 8010132
Source Documents#
Other 510(k) Records For Product Code CGF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935013 | DSL ESTRONE (DSL 8700) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | Diagnostics Biochem Canada, Inc. | 1987-01-09 |
| K833406 | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | Corning Medical & Scientific | 1984-01-24 |
Legacy Summary#
summary
FDA Review#
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