The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Acth Ria.
| Device ID | K844181 |
| 510k Number | K844181 |
| Device Name: | ACTH RIA |
| Classification | Radioimmunoassay, Acth |
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-26 |
| Decision Date | 1984-11-27 |