FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K Number: K863099
·
Decision Sep 16, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
883
Review Days
34
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Basic Information
- Device Name
- ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
- K Number
- K863099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2720
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- August 13, 1986
- Decision Date
- September 16, 1986
- Product Code
- JJK
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JJK | Oncometer, Plasma, For Clinical Use | FDA class 1 | Clinical Chemistry |
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FDA 510(k)
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