MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
FDA 510(k) clearance K002199 · decided 2000-11-20
Clearance details
- K-number
- K002199
- Device name
- MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2000-07-20
- Decision date
- 2000-11-20
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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