FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
K Number: K130765
·
Decision Apr 4, 2013
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
17
Review Days
15
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Basic Information
- Device Name
- ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
- K Number
- K130765
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elitechgroup
- Date Received
- March 20, 2013
- Decision Date
- April 4, 2013
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Oct 3, 2012 | Substantially Equivalent |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Aug 22, 2012 | Substantially Equivalent |