The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Glucose (hexokinase).
| Device ID | K011900 |
| 510k Number | K011900 |
| Device Name: | GLUCOSE (HEXOKINASE) |
| Classification | Hexokinase, Glucose |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2001-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274022832 | K011900 | 000 |
| 00817274022542 | K011900 | 000 |
| 00817274021583 | K011900 | 000 |