The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Modified Amerlex-m Progesterone Radioimmuno. Kit.
| Device ID | K880934 |
| 510k Number | K880934 |
| Device Name: | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT |
| Classification | Radioimmunoassay, Progesterone |
| 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 | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-04-18 |