Clearblue® Early Digital Pregnancy Test— 510(k) K200913
Substantially EquivalentSpd Swiss Precision Diagnostics GmbH
FDA 510(k) clearance K200913 for Clearblue® Early Digital Pregnancy Test, Substantially Equivalent on 2021-08-13. Applicant: Spd Swiss Precision Diagnostics GmbH. Device class: 2.
Clearance details
- Applicant
- Spd Swiss Precision Diagnostics GmbH
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, CH
Recent devices under product code LCX
view all- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
More clearances from Spd Swiss Precision Diagnostics GmbH
view allRecalls naming K200913
K-number listed on FDA's recall record- Z-0261-2024 — CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
- Z-1526-2022 — CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.