FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
K Number: K122858
·
Decision Oct 3, 2012
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
17
Review Days
15
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Basic Information
- Device Name
- ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
- K Number
- K122858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elitechgroup
- Date Received
- September 18, 2012
- Decision Date
- October 3, 2012
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFJ), ordered by most recent decision date.
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HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
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SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
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EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
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Other Clearances by Elitechgroup
| K Number | Device Name | ||
|---|---|---|---|
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| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Jul 11, 2017 | Substantially Equivalent |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Sep 7, 2016 | Substantially Equivalent |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Jul 22, 2015 | Substantially Equivalent |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Jul 8, 2015 | Substantially Equivalent |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Jul 18, 2014 | Substantially Equivalent |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Jan 3, 2014 | Substantially Equivalent |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Apr 4, 2013 | Substantially Equivalent |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | Feb 15, 2013 | Substantially Equivalent |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Aug 22, 2012 | Substantially Equivalent |