The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Control, Hematology, Ch-60.
| Device ID | K781077 |
| 510k Number | K781077 |
| Device Name: | CONTROL, HEMATOLOGY, CH-60 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-28 |
| Decision Date | 1978-07-27 |