The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Progesterone Radioimmunoassay Kit.
| Device ID | K864855 |
| 510k Number | K864855 |
| Device Name: | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Donald E Baker |
| Correspondent | Donald E Baker AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-02-25 |