FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOME ACCESS AIC TEST
K Number: K141944
·
Decision Mar 13, 2015
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
2
Review Days
239
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Basic Information
- Device Name
- HOME ACCESS AIC TEST
- K Number
- K141944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Home Access Health Corp.
- Date Received
- July 17, 2014
- Decision Date
- March 13, 2015
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Home Access Health Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063852 | ACCESSA CHOLESTEROL PANEL | Nov 9, 2007 | Substantially Equivalent |