The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amersham Tsh Control Sera.
| Device ID | K902760 |
| 510k Number | K902760 |
| Device Name: | AMERSHAM TSH CONTROL SERA |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-25 |
| Decision Date | 1990-07-27 |