The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus(r) Ck-mb.
| Device ID | K924429 |
| 510k Number | K924429 |
| Device Name: | OPUS(R) CK-MB |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nanc M Johansen |
| Correspondent | Nanc M Johansen PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-01 |
| Decision Date | 1992-10-15 |