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
- Product 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- K262299 — Instant-View® hCG Combo II Cassette Test
- 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)
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.