The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade(r) Ck-mb/myoglobin Immun Control, I,ii,iii.
| Device ID | K926046 |
| 510k Number | K926046 |
| Device Name: | DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Charla Issitt |
| Correspondent | Charla Issitt BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-01-05 |