The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Hemoglobin Reagent.
Device ID | K821658 |
510k Number | K821658 |
Device Name: | HEMOGLOBIN REAGENT |
Classification | Whole Blood Hemoglobin Determination |
Applicant | ANCO MEDICAL REAGENTS & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KHG |
CFR Regulation Number | 864.7500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-04 |
Decision Date | 1982-06-25 |