FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOCHEK S.C. WITH AUDIO OPTION
K Number: K871586
·
Decision Sep 16, 1987
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
3
Review Days
146
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Basic Information
- Device Name
- GLUCOCHEK S.C. WITH AUDIO OPTION
- K Number
- K871586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Larken Industries, Inc.
- Date Received
- April 23, 1987
- Decision Date
- September 16, 1987
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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