The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus(tm) Digoxin Test System.
| Device ID | K901547 |
| 510k Number | K901547 |
| Device Name: | OPUS(TM) DIGOXIN TEST SYSTEM |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-06-26 |