The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Quick Start Creatine Kinase(ck) Item #5a17.
| Device ID | K912807 |
| 510k Number | K912807 |
| Device Name: | ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 |
| Classification | Enzymatic Method, Creatinine |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-10-31 |