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 |