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
67
Registration Numbers
68
Same Product Code
72
Applicant Total
3
Review Days
347
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFR), ordered by most recent decision date.
FreeStyle InsuLinx Blood Glucose Monotioring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK AVIVA EXPERT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry