Clearblue® Early Digital Pregnancy Test
FDA 510(k) clearance K200913 · decided 2021-08-13
Clearance details
- K-number
- K200913
- Device name
- Clearblue® Early Digital Pregnancy Test
- Applicant
- Spd Swiss Precision Diagnostics GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-04-06
- Decision date
- 2021-08-13
- Days to decision
- 494 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Geneva, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 recall (Z-0261-2024) | Family Dollar Stores, Llc. | 2023-11-07 |
| CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 recall (Z-1526-2022) | Family Dollar Stores, Llc. | 2022-08-17 |