FIRST RESPONSE EARLY RESULT PREGNANCY TEST
FDA 510(k) clearance K123436 · decided 2013-08-26
Clearance details
- K-number
- K123436
- Device name
- FIRST RESPONSE EARLY RESULT PREGNANCY TEST
- Applicant
- Church & Dwight Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-07
- Decision date
- 2013-08-26
- Days to decision
- 292 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 |
|---|---|---|
| FIRST RESPONSE 2 CT, SKU 902343 recall (Z-0266-2024) | Family Dollar Stores, Llc. | 2023-11-07 |
| FIRST RESPONSE 2 CT, SKU 902343 recall (Z-1537-2022) | Family Dollar Stores, Llc. | 2022-08-17 |