The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Fisher Diagnostics Hematall-c Calibrator.
| Device ID | K862318 |
| 510k Number | K862318 |
| Device Name: | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR |
| Classification | Mixture, Hematology Quality Control |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer 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 | 1986-06-18 |
| Decision Date | 1986-07-10 |