The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Hematall-c Plus Hematology Controls.
| Device ID | K863224 |
| 510k Number | K863224 |
| Device Name: | HEMATALL-C PLUS HEMATOLOGY CONTROLS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles Breuer,ph.d. |
| Correspondent | Charles Breuer,ph.d. FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1986-10-29 |