FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IBL CORTISOL LIA TEST KIT
K Number: K052359
·
Decision Oct 3, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
2
Review Days
38
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Basic Information
- Device Name
- IBL CORTISOL LIA TEST KIT
- K Number
- K052359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lehnus & Associates Consulting
- Date Received
- August 26, 2005
- Decision Date
- October 3, 2005
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
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Other Clearances by Lehnus & Associates Consulting
| K Number | Device Name | ||
|---|---|---|---|
| K103574 | PREGNANCY ONE STEP RAPID TEST | Jul 28, 2011 | Substantially Equivalent |