FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K Number: K153644
·
Decision Sep 7, 2016
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
17
Review Days
261
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Basic Information
- Device Name
- ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
- K Number
- K153644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elitechgroup
- Date Received
- December 21, 2015
- Decision Date
- September 7, 2016
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Elitechgroup
| K Number | Device Name | ||
|---|---|---|---|
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Oct 29, 2018 | Substantially Equivalent |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Jul 11, 2017 | 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 |
| 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 |