The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Digoxin & Phenytoin Control Sera.
Device ID | K803097 |
510k Number | K803097 |
Device Name: | DIGOXIN & PHENYTOIN CONTROL SERA |
Classification | Drug Mixture Control Materials |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-08 |
Decision Date | 1980-12-22 |