DAVID PREGNANCY TEST (MIDSTREAM)— 510(k) K053236
Substantially EquivalentRunbio Biotech Co.,Ltd
FDA 510(k) clearance K053236 for DAVID PREGNANCY TEST (MIDSTREAM), Substantially Equivalent on 2006-07-18. Applicant: Runbio Biotech Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Runbio Biotech Co.,Ltd
- 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
- Tacoma, WA, US
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 Runbio Biotech Co.,Ltd
view all- K181551 — DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
- K172627 — David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Data sourced from openFDA. This site is unofficial and independent of the FDA.