FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K Number: K032987
·
Decision Nov 17, 2003
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
374
Applicant Total
3
Review Days
54
Basic Information
- Device Name
- ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
- K Number
- K032987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- UNOTECH DIAGNOSTICS, INC.
- Date Received
- September 24, 2003
- Decision Date
- November 17, 2003
- 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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