The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Reagent For Determ. Inorganic/phosphorus.
Device ID | K800690 |
510k Number | K800690 |
Device Name: | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | DIAGNOSTIC SOLUTIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-26 |
Decision Date | 1980-05-28 |