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 |