The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Ferro-quant Tm Fe 59 Test Kit.
Device ID | K800868 |
510k Number | K800868 |
Device Name: | FERRO-QUANT TM FE 59 TEST KIT |
Classification | Radiometric, Fe59, Iron Binding Capacity |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQG |
CFR Regulation Number | 862.1415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-17 |
Decision Date | 1980-04-29 |