FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA CORTISOL ASSAY
K Number: K893954
·
Decision Oct 31, 1989
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
18
Applicant Total
107
Review Days
152
Basic Information
- Device Name
- CEDIA CORTISOL ASSAY
- K Number
- K893954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MICROGENICS CORP.
- Date Received
- June 1, 1989
- Decision Date
- October 31, 1989
- Product Code
- JFT
- 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 |
|---|---|---|---|
| JFT | Fluorometric, Cortisol | FDA class 2 | Clinical Chemistry |
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