FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
On Call Express II Blood Glucose Monitoring System
K Number: K192175
·
Decision Oct 17, 2019
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
85
Review Days
66
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Basic Information
- Device Name
- On Call Express II Blood Glucose Monitoring System
- K Number
- K192175
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ACON Laboratories, Inc.
- Date Received
- August 12, 2019
- Decision Date
- October 17, 2019
- Product Code
- NBW
- 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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