The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Specific Estrol(unconjugated) Ria Kit.
| Device ID | K912733 |
| 510k Number | K912733 |
| Device Name: | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-20 |
| Decision Date | 1991-07-22 |