The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Spac Digoxin Kit.
Device ID | K760800 |
510k Number | K760800 |
Device Name: | SPAC DIGOXIN KIT |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DON |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-08 |
Decision Date | 1976-11-01 |