The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Kits, Ria, Myoglobin, Human, Measurement.
| Device ID | K780982 |
| 510k Number | K780982 |
| Device Name: | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-06-22 |