FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Access Testosterone
K Number: K223405
·
Decision Jan 13, 2023
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
87
Applicant Total
24
Review Days
65
Basic Information
- Device Name
- Access Testosterone
- K Number
- K223405
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- November 9, 2022
- Decision Date
- January 13, 2023
- 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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