The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Quickstart Ld-1, Modification.
| Device ID | K925188 |
| 510k Number | K925188 |
| Device Name: | ABBOTT QUICKSTART LD-1, MODIFICATION |
| Classification | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JGF |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-08 |
| Decision Date | 1993-02-05 |