FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODATA TESTOSTERONE MAIA KIT
K Number: K955102
·
Decision Jun 24, 1996
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
4
Review Days
229
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Basic Information
- Device Name
- BIODATA TESTOSTERONE MAIA KIT
- K Number
- K955102
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biochem Immunosystems (U.S.), Inc.
- Date Received
- November 8, 1995
- Decision Date
- June 24, 1996
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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