The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for Haem-c Plus Blood Reference Controls.
| Device ID | K821956 |
| 510k Number | K821956 |
| Device Name: | HAEM-C PLUS BLOOD REFERENCE CONTROLS |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | BAKER INSTRUCTIONS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-30 |
| Decision Date | 1982-07-30 |