Panels › Clinical Chemistry › Product code CGF · Class 1
Radioimmunoassay, Estrone
Regulation 862.1280
0510(k)s in 12 months (4 all time)
1recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in CGF
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 2 |
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| Immunotech A.S. | 0 | 2 |
| Corning Medical & Scientific | 1 | 0 |
| Diagnostics Biochem Canada, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 1997 | K970915 | DSL ESTRONE-SULFATE RIA Diagnostic Systems Laboratories, Inc. | CGF |
| Jun 16, 1994 | K935013 | DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc. | CGF |
| Jan 9, 1987 | K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE Diagnostics Biochem Canada, Inc., CA | CGF |
| Jan 24, 1984 | K833406 | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY Corning Medical & Scientific | CGF |
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