IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT— 510(k) K050741
Substantially EquivalentInd Diagnostic, Inc.
FDA 510(k) clearance K050741 for IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT, Substantially Equivalent on 2005-05-16. Applicant: Ind Diagnostic, Inc.. Device class: 2.
Clearance details
- Applicant
- Ind Diagnostic, 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
- Delta, 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 Ind Diagnostic, 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 K050741
K-number listed on FDA's recall record- Z-0048-2024 — DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
- Z-0064-2024 — DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050741.
Data sourced from openFDA. This site is unofficial and independent of the FDA.