The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Thyroid Control Sera Code Qas.101.
Device ID | K790840 |
510k Number | K790840 |
Device Name: | THYROID CONTROL SERA CODE QAS.101 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-02 |
Decision Date | 1979-06-28 |