FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESENSOR RESPIRATORY VIRAL PANEL
K Number: K113731
·
Decision Sep 10, 2012
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
2
Review Days
266
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Basic Information
- Device Name
- ESENSOR RESPIRATORY VIRAL PANEL
- K Number
- K113731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Micro Sensors, Inc.
- Date Received
- December 19, 2011
- Decision Date
- September 10, 2012
- Product Code
- JJH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JJH | Clinical Sample Concentrator | FDA class 1 | Clinical Chemistry |
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Other Clearances by Clinical Micro Sensors, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | Mar 28, 2006 | Substantially Equivalent |