The following data is part of a premarket notification filed by Science Regulatory Services Intl. with the FDA for Acth Irma Kit Mitsubishi Yuka.
| Device ID | K910178 |
| 510k Number | K910178 |
| Device Name: | ACTH IRMA KIT MITSUBISHI YUKA |
| Classification | Radioimmunoassay, Acth |
| Applicant | SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW Washington, DC 20006 |
| Contact | Michael G Farrow |
| Correspondent | Michael G Farrow SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW 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 | 1991-01-15 |
| Decision Date | 1991-05-22 |