The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Im 2050 Amerlex Free T4 Ria Kit.
Device ID | K810231 |
510k Number | K810231 |
Device Name: | CODE IM 2050 AMERLEX FREE T4 RIA KIT |
Classification | Radioimmunoassay, Free Thyroxine |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-27 |
Decision Date | 1981-02-10 |