The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Free T-4 Radioimmunoassay Kit.
Device ID | K842482 |
510k Number | K842482 |
Device Name: | AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT |
Classification | Radioimmunoassay, Free Thyroxine |
Applicant | AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-25 |
Decision Date | 1984-08-10 |