FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K Number: K043175
·
Decision Nov 24, 2004
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
264
Review Days
8
Basic Information
- Device Name
- ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
- K Number
- K043175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Date Received
- November 16, 2004
- Decision Date
- November 24, 2004
- Product Code
- NHG
- 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 |
|---|---|---|---|
| NHG | Enzyme Immunoassay, Cortisol, Salivary | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHG), ordered by most recent decision date.
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ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
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HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
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HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
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| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Mar 19, 2010 | Substantially Equivalent |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |