GLUCOSE (HEXOKINASE)
FDA 510(k) clearance K011900 · decided 2001-07-31
Clearance details
- K-number
- K011900
- Device name
- GLUCOSE (HEXOKINASE)
- Applicant
- Jas Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-18
- Decision date
- 2001-07-31
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose recall (Z-0827-2015) | JAS Diagnostics Inc. | 2014-12-18 |
| Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose i recall (Z-1873-2014) | JAS Diagnostics Inc. | 2014-06-25 |