The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Glucose (hk) - Incorporating Dynamic Stabilization Technology - (dst).
| Device ID | K980026 |
| 510k Number | K980026 |
| Device Name: | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
| Classification | Hexokinase, Glucose |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE AMERICA, INC. 7260 NORTH WEST 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 | 1998-01-05 |
| Decision Date | 1998-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275002423 | K980026 | 000 |