The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Lactate Dehydrogenase (epos Appl) #65476.
| Device ID | K910640 |
| 510k Number | K910640 |
| Device Name: | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-04-12 |