The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Radioassay Controls 31 & 32, Anti-dsdna Control.
| Device ID | K894329 |
| 510k Number | K894329 |
| Device Name: | RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-05 |