ONE STEP MIDSTREAM HCG PREGNANCY TEST— 510(k) K974059
Substantially EquivalentInternational Newtech Development, Inc.
FDA 510(k) clearance K974059 for ONE STEP MIDSTREAM HCG PREGNANCY TEST, Substantially Equivalent on 1998-04-09. Applicant: International Newtech Development, Inc.. Device class: 2.
Clearance details
- Applicant
- International Newtech Development, 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 International Newtech Development, Inc.
view allRecalls naming K974059
K-number listed on FDA's recall record- Z-0049-2024 — Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
- Z-0055-2024 — PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
- Z-0066-2024 — DiagnosUS Pregnancy Test Midstream REF 100-17
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974059.
Data sourced from openFDA. This site is unofficial and independent of the FDA.