FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
K Number: K870708
·
Decision Feb 2, 1988
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
72
Applicant Total
3
Review Days
347
Basic Information
- Device Name
- GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
- K Number
- K870708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- KYOTO DAIICHI KAGAKU CO., LTD.
- Date Received
- February 20, 1987
- Decision Date
- February 2, 1988
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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