FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT TESTPACK (TM) HCG SERUM
K Number: K863032
·
Decision Sep 15, 1986
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
374
Applicant Total
857
Review Days
35
Basic Information
- Device Name
- ABBOTT TESTPACK (TM) HCG SERUM
- K Number
- K863032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- August 11, 1986
- Decision Date
- September 15, 1986
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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