The following data is part of a premarket notification filed by Jas Diagnostic, Inc. with the FDA for Urea Nitrogen (bun) Liquid Reagent.
Device ID | K011596 |
510k Number | K011596 |
Device Name: | UREA NITROGEN (BUN) LIQUID REAGENT |
Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
Applicant | JAS DIAGNOSTIC, INC. 7220 NW 58TH ST. Miami, FL 33166 |
Contact | David Johnston |
Correspondent | David Johnston JAS DIAGNOSTIC, INC. 7220 NW 58TH ST. Miami, FL 33166 |
Product Code | CDQ |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-24 |
Decision Date | 2001-07-17 |
Summary: | summary |