The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Emds Glucose (glu-hk) Test, Item 65415.
| Device ID | K924572 |
| 510k Number | K924572 |
| Device Name: | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-10 |
| Decision Date | 1992-11-25 |