The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-nak-50 Test Kit.
Device ID | K831300 |
510k Number | K831300 |
Device Name: | MSI-NAK-50 TEST KIT |
Classification | Flame Photometry, Potassium |
Applicant | MEDICAL SPECIALTIES, INC. 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 | 1983-04-21 |
Decision Date | 1983-07-18 |