The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Sucrosep Human Prolactin (hpr) Irma.
| Device ID | K861271 |
| 510k Number | K861271 |
| Device Name: | SUCROSEP HUMAN PROLACTIN (HPR) IRMA |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | John G Simpson |
| Correspondent | John G Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-04 |
| Decision Date | 1986-06-27 |