The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Magnesium Reagent.
Device ID | K003835 |
510k Number | K003835 |
Device Name: | JAS MAGNESIUM REAGENT |
Classification | Photometric Method, Magnesium |
Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
Contact | David Johnston |
Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-12 |
Decision Date | 2001-03-23 |