The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite(tm) Prolactin-30 Assay, Lan.0086/2086.
| Device ID | K914135 |
| 510k Number | K914135 |
| Device Name: | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Kathryn B Patterson |
| Correspondent | Kathryn B Patterson 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 | 1991-09-16 |
| Decision Date | 1992-02-18 |