FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K Number: K120900
·
Decision May 31, 2013
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
36
Review Days
431
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Basic Information
- Device Name
- I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
- K Number
- K120900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cliniqa Corporation
- Date Received
- March 26, 2012
- Decision Date
- May 31, 2013
- Product Code
- GGN
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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Other Clearances by Cliniqa Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | May 18, 2012 | Substantially Equivalent |
| K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | Apr 21, 2009 | Substantially Equivalent |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | Jan 16, 2009 | Substantially Equivalent |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Sep 17, 2008 | Substantially Equivalent |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | Jun 2, 2008 | Substantially Equivalent |
| K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | May 4, 2007 | Substantially Equivalent |
| K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | Oct 23, 2006 | Substantially Equivalent |
| K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | May 25, 2006 | Substantially Equivalent |
| K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | Mar 21, 2006 | Substantially Equivalent |
| K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E | Nov 18, 2005 | Substantially Equivalent |