FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUDIT MICROCV HS-CRP LINEARITY SET
K Number: K101427
·
Decision Dec 23, 2010
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
35
Review Days
216
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Basic Information
- Device Name
- AUDIT MICROCV HS-CRP LINEARITY SET
- K Number
- K101427
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aalto Scientific, Ltd.
- Date Received
- May 21, 2010
- Decision Date
- December 23, 2010
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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