The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Testosterone Coated Tubes Radioimmunoassay Kit.
| Device ID | K860130 |
| 510k Number | K860130 |
| Device Name: | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Contact | Sandra Fan |
| Correspondent | Sandra Fan CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-02-19 |