The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for T4 No Spin(tm) Coated Tube Radioimmunoassay Kit.
| Device ID | K870573 |
| 510k Number | K870573 |
| Device Name: | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Total Thyroxine |
| 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 | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-04-22 |