The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Quick-count Hematology Controls.
| Device ID | K851663 |
| 510k Number | K851663 |
| Device Name: | QUICK-COUNT HEMATOLOGY CONTROLS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullvan |
| Correspondent | Michael J Sullvan SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-07-23 |