FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
FDA 510(k) clearance K083716 · decided 2009-06-08
Clearance details
- K-number
- K083716
- Device name
- FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
- Applicant
- Church & Dwight Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-15
- Decision date
- 2009-06-08
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of conve recall (Z-1350-2023) | Church & Dwight Inc | 2023-04-07 |