The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Calcium (arsenazo) Reagent.
Device ID | K011441 |
510k Number | K011441 |
Device Name: | JAS CALCIUM (ARSENAZO) REAGENT |
Classification | Azo Dye, Calcium |
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 | CJY |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-10 |
Decision Date | 2001-07-09 |