The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Becton Dickinson Thyroid Stimulating Hormone Syste.
| Device ID | K925132 |
| 510k Number | K925132 |
| Device Name: | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1992-12-28 |