FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K Number: K130255
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
883
Review Days
392
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Basic Information
- Device Name
- HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
- K Number
- K130255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- February 1, 2013
- Decision Date
- February 28, 2014
- Product Code
- PDJ
- 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 |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | FDA class 2 | Clinical Chemistry |
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