FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
K Number: K051733
·
Decision Dec 7, 2005
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
6
Applicant Total
4
Review Days
162
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Basic Information
- Device Name
- ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
- K Number
- K051733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drg Intl., Inc.
- Date Received
- June 28, 2005
- Decision Date
- December 7, 2005
- 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 |
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