The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Specific Estriol Unconjugated.
| Device ID | K844408 |
| 510k Number | K844408 |
| Device Name: | AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED |
| Classification | Radioimmunoassay, Estriol |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-14 |
| Decision Date | 1984-12-11 |