HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)— 510(k) K123703
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K123703 for HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE), Substantially Equivalent on 2013-04-10. Applicant: Healgen Scientific,, LLC. Device class: 2.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- 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
- Houston, TX, 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 Healgen Scientific,, LLC
view allRecalls naming K123703
K-number listed on FDA's recall record- Z-0264-2024 — VERIQUICK PREGNANCY TEST 1CT, SKU 901260
- Z-1527-2022 — VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
- Z-1528-2022 — Veriquick Pregnancy Test 2CT, SKU 903756
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123703.
Data sourced from openFDA. This site is unofficial and independent of the FDA.