FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K Number: K000102
·
Decision Feb 8, 2000
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
51
Review Days
26
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Basic Information
- Device Name
- GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
- K Number
- K000102
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- January 13, 2000
- Decision Date
- February 8, 2000
- Product Code
- CFR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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