FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-GENT LIQUID TOTAL BILIRUBIN
K Number: K860424
·
Decision Apr 3, 1986
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
233
Applicant Total
857
Review Days
58
Basic Information
- Device Name
- A-GENT LIQUID TOTAL BILIRUBIN
- K Number
- K860424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- February 4, 1986
- Decision Date
- April 3, 1986
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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