The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Reproductive Endocrinology (label Change).
| Device ID | K890708 |
| 510k Number | K890708 |
| Device Name: | AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-31 |
| Decision Date | 1989-03-20 |