The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Ad150, Automated Hematology Dilutor.
Device ID | K852373 |
510k Number | K852373 |
Device Name: | AD150, AUTOMATED HEMATOLOGY DILUTOR |
Classification | Apparatus, Automated Blood Cell Diluting |
Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
Contact | Ruth M Becker |
Correspondent | Ruth M Becker ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
Product Code | GKH |
CFR Regulation Number | 864.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-04 |
Decision Date | 1985-07-05 |