FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
K Number: K130762
·
Decision Apr 29, 2013
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
35
Review Days
40
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Basic Information
- Device Name
- AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
- K Number
- K130762
- 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
- March 20, 2013
- Decision Date
- April 29, 2013
- 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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|---|---|---|---|
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| K143571 | Audit MicroControls Linearity LQ Cystatin-C | Jan 23, 2015 | Substantially Equivalent |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Jan 16, 2015 | Substantially Equivalent |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | Nov 21, 2014 | Substantially Equivalent |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Nov 20, 2014 | Substantially Equivalent |
| K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET | Apr 26, 2013 | Substantially Equivalent |
| K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET | Mar 19, 2013 | Substantially Equivalent |
| K112742 | AUDIT MICROLQ SPINAL FLUID CONTROL | Jun 15, 2012 | Substantially Equivalent |
| K111964 | AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY | Mar 2, 2012 | Substantially Equivalent |