The following data is part of a premarket notification filed by Mitsubishi Yuka America, Inc. with the FDA for Calcitonin Kit Mitsubishi Yuka.
| Device ID | K912536 |
| 510k Number | K912536 |
| Device Name: | CALCITONIN KIT MITSUBISHI YUKA |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington, DC 20006 |
| Contact | Michael G Farrow |
| Correspondent | Michael G Farrow MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington, DC 20006 |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-07 |
| Decision Date | 1991-07-18 |