The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Prolactin Assay, Lan.0078/2078(240/144).
| Device ID | K883878 |
| 510k Number | K883878 |
| Device Name: | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-01 |