MINI STRIP/SERUM HCG— 510(k) K963132
Substantially EquivalentInternational Newtech Development, Inc.
FDA 510(k) clearance K963132 for MINI STRIP/SERUM HCG, Substantially Equivalent on 1996-11-18. Applicant: International Newtech Development, Inc.. Device class: 2.
Clearance details
- Applicant
- International Newtech Development, Inc.
- Product code
- Code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, B.C., CA
Recent devices under product code JHI
view all- K241919 — Innovita HCG Pregnancy Rapid Combo Test
- K203272 — Alltest Pregnancy Rapid Combo Test Cassette
- K172322 — Atellica IM Total hCG (ThCG)
- K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
More clearances from International Newtech Development, Inc.
view allAdverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K963132
K-number listed on FDA's recall record- Z-0050-2024 — To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
- Z-0061-2024 — Lem Fertility hCG Pregnancy Urine Test REF 100-12
- Z-0063-2024 — DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963132.
Data sourced from openFDA. This site is unofficial and independent of the FDA.