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 |