The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Glucose Test Item Number 97375/94.
| Device ID | K951750 |
| 510k Number | K951750 |
| Device Name: | GLUCOSE TEST ITEM NUMBER 97375/94 |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EMD CHEMICALS INC. 480 SOUTH DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-09-06 |