FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K Number: K031644
·
Decision Jun 25, 2003
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
46
Review Days
29
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Basic Information
- Device Name
- BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
- K Number
- K031644
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- May 27, 2003
- Decision Date
- June 25, 2003
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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