FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
K Number: K101089
·
Decision Jul 13, 2011
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
47
Review Days
450
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Basic Information
- Device Name
- EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
- K Number
- K101089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corp.
- Date Received
- April 19, 2010
- Decision Date
- July 13, 2011
- Product Code
- DCF
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Medica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Mar 1, 2013 | Substantially Equivalent |
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | May 14, 2012 | Substantially Equivalent |
| K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | Dec 6, 2011 | Substantially Equivalent |
| K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | Nov 15, 2011 | Substantially Equivalent |
| K112788 | EASTLYTE NA/K/CA/PH | Oct 20, 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 |
| K092116 | EASYCELL CELL LOCATOR | May 12, 2010 | Substantially Equivalent |