FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
K Number: K093883
·
Decision Sep 20, 2010
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
6
Review Days
276
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Basic Information
- Device Name
- AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
- K Number
- K093883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seppim S.A.S.
- Date Received
- December 18, 2009
- Decision Date
- September 20, 2010
- Product Code
- CIT
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
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Other Clearances by Seppim S.A.S.
| K Number | Device Name | ||
|---|---|---|---|
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | Nov 18, 2011 | Substantially Equivalent |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | May 19, 2011 | Substantially Equivalent |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | May 19, 2011 | Substantially Equivalent |
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | May 6, 2011 | Substantially Equivalent |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | Dec 15, 2010 | Substantially Equivalent |