FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K Number: K041866
·
Decision Sep 29, 2004
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
24
Review Days
82
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Basic Information
- Device Name
- ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
- K Number
- K041866
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Date Received
- July 9, 2004
- Decision Date
- September 29, 2004
- 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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