The following data is part of a premarket notification filed by Hycel, Inc. with the FDA for Royco Model 970 Hematology Data Analyzer.
| Device ID | K780946 |
| 510k Number | K780946 |
| Device Name: | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER |
| Classification | Red-cell Indices, Calculated |
| Applicant | HYCEL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPJ |
| CFR Regulation Number | 864.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-09 |
| Decision Date | 1978-07-27 |