The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Iq Immunochemistry Sistem; Iq Tsh Assay.
| Device ID | K923060 |
| 510k Number | K923060 |
| Device Name: | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1992-09-15 |