The following data is part of a premarket notification filed by American Dade with the FDA for Dade Hematology Calibrator Plus.
Device ID | K840010 |
510k Number | K840010 |
Device Name: | DADE HEMATOLOGY CALIBRATOR PLUS |
Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRZ |
CFR Regulation Number | 864.8165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-04 |
Decision Date | 1984-04-19 |