The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Inorganic Phosphorus Reagent Set.
Device ID | K813400 |
510k Number | K813400 |
Device Name: | INORGANIC PHOSPHORUS REAGENT SET |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | ANCO MEDICAL REAGENTS & ASSOC. 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 | 1981-12-04 |
Decision Date | 1981-12-22 |