The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms - Digoxin.
| Device ID | K913562 |
| 510k Number | K913562 |
| Device Name: | QMS - DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i) |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LCS |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-08-30 |