The following data is part of a premarket notification filed by Btc Diagnostics, Inc. with the FDA for Enzyme Immunoassay For Detection Horm.
| Device ID | K841545 |
| 510k Number | K841545 |
| Device Name: | ENZYME IMMUNOASSAY FOR DETECTION HORM |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | BTC DIAGNOSTICS, INC. 61 MOULTON STREET Cambridge , MA 02138 - |
| Contact | Walter D Cantarow |
| Correspondent | Walter D Cantarow BTC DIAGNOSTICS, INC. 61 MOULTON STREET Cambridge , MA 02138 - |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-11-27 |