IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)— 510(k) K110889
Substantially EquivalentInd Diagnostics, Inc.
FDA 510(k) clearance K110889 for IND ONE STEP HCG URINE PREGNANCY TEST (STRIP), Substantially Equivalent on 2011-06-20. Applicant: Ind Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ind Diagnostics, Inc.
- 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
- Delta, B.C., CA
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 Ind Diagnostics, Inc.
view allRecalls naming K110889
K-number listed on FDA's recall record- Z-0042-2024 — One Step Pregnancy Test REF 100-01
- Z-0053-2024 — PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
- Z-0054-2024 — PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110889.
Data sourced from openFDA. This site is unofficial and independent of the FDA.