The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Ck-mb Immunoassay Control.
| Device ID | K905623 |
| 510k Number | K905623 |
| Device Name: | CK-MB IMMUNOASSAY CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| 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 | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-02-22 |