The following data is part of a premarket notification filed by Intercare Diagnostics, Inc. with the FDA for Hematology Control Mixtures For Quality Control.
| Device ID | K893895 |
| 510k Number | K893895 |
| Device Name: | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | INTERCARE DIAGNOSTICS, INC. P.O. BOX 24124 Baltimore, MD 21227 |
| Contact | Eduardo Ugarte |
| Correspondent | Eduardo Ugarte INTERCARE DIAGNOSTICS, INC. P.O. BOX 24124 Baltimore, MD 21227 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-07-25 |