FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K Number: K854177
·
Decision Nov 25, 1985
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
36
Review Days
41
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Basic Information
- Device Name
- IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
- K Number
- K854177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- October 15, 1985
- Decision Date
- November 25, 1985
- 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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