The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Sodium & Potassium Test Kit.
Device ID | K810253 |
510k Number | K810253 |
Device Name: | SODIUM & POTASSIUM TEST KIT |
Classification | Flame Photometry, Potassium |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JGM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-30 |
Decision Date | 1981-02-10 |