FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K Number: K070207
·
Decision Apr 13, 2007
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
74
Review Days
81
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Basic Information
- Device Name
- MULTI-ANALYTE CHEMISTRY CALIBRATOR
- K Number
- K070207
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pointe Scientific, Inc.,
- Date Received
- January 22, 2007
- Decision Date
- April 13, 2007
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pointe Scientific, Inc.,
| K Number | Device Name | ||
|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Dec 4, 2007 | Substantially Equivalent |
| K062118 | POINTE 360 | Jul 13, 2007 | Substantially Equivalent |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Apr 30, 2007 | Substantially Equivalent |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | Apr 11, 2007 | Substantially Equivalent |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Mar 28, 2007 | Substantially Equivalent |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | Oct 7, 2005 | Substantially Equivalent |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Jun 2, 2004 | Substantially Equivalent |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Aug 6, 2003 | Substantially Equivalent |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Apr 28, 2003 | Substantially Equivalent |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Mar 31, 2003 | Substantially Equivalent |