The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Luteinizing Hormone Radioimmuno-kit.
| Device ID | K851104 |
| 510k Number | K851104 |
| Device Name: | AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Philip M Frantasia |
| Correspondent | Philip M Frantasia AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-04-10 |