FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
K Number: K080404
·
Decision Mar 13, 2009
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
47
Review Days
393
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Basic Information
- Device Name
- EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
- K Number
- K080404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corp.
- Date Received
- February 14, 2008
- Decision Date
- March 13, 2009
- 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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|---|---|---|---|
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| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Apr 21, 2011 | Substantially Equivalent |
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| K100829 | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 | Jan 14, 2011 | Substantially Equivalent |