The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for No Spin(tm) T3 Coated Tube Radioimmunoassay.
| Device ID | K873737 |
| 510k Number | K873737 |
| Device Name: | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Contact | Anne M Kulis |
| Correspondent | Anne M Kulis CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1987-11-24 |