The following data is part of a premarket notification filed by Seradyn with the FDA for Qms Digoxin Reagent System On The Abbott Aeroset System.
| Device ID | K023058 |
| 510k Number | K023058 |
| Device Name: | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Contact | Lisa Brown |
| Correspondent | Lisa Brown SERADYN 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-13 |
| Decision Date | 2002-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740135324 | K023058 | 000 |
| 00380740000240 | K023058 | 000 |
| 00380740000233 | K023058 | 000 |