FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
K Number: K090734
·
Decision Jul 17, 2009
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
47
Review Days
120
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Basic Information
- Device Name
- EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
- K Number
- K090734
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corp.
- Date Received
- March 19, 2009
- Decision Date
- July 17, 2009
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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Other Clearances by Medica Corp.
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|---|---|---|---|
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| K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | Dec 6, 2011 | Substantially Equivalent |
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| K112788 | EASTLYTE NA/K/CA/PH | Oct 20, 2011 | Substantially Equivalent |
| K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | Jul 13, 2011 | Substantially Equivalent |
| K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | May 20, 2011 | Substantially Equivalent |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Apr 21, 2011 | Substantially Equivalent |
| K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT | Apr 4, 2011 | Substantially Equivalent |
| K100829 | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 | Jan 14, 2011 | Substantially Equivalent |