FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K Number: K083716
·
Decision Jun 8, 2009
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
223
Applicant Total
19
Review Days
175
Basic Information
- Device Name
- FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
- K Number
- K083716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CHURCH & DWIGHT CO., INC.
- Date Received
- December 15, 2008
- Decision Date
- June 8, 2009
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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