FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K Number: K111996
·
Decision Sep 14, 2011
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
17
Review Days
63
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Basic Information
- Device Name
- ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
- K Number
- K111996
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elitechgroup
- Date Received
- July 13, 2011
- Decision Date
- September 14, 2011
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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