The following data is part of a premarket notification filed by Mitsubishi Yuka America, Inc. with the FDA for Acth Irma Kit Ii Mitsubishi Yuka.
| Device ID | K915727 |
| 510k Number | K915727 |
| Device Name: | ACTH IRMA KIT II MITSUBISHI YUKA |
| Classification | Radioimmunoassay, Acth |
| Applicant | MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington, DC 20006 |
| Contact | Michael Farrow |
| Correspondent | Michael Farrow MITSUBISHI YUKA AMERICA, INC. 1625 K ST. N.W. SUITE 1000 Washington, DC 20006 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-03-02 |