RESULT PLUS/HCG PREGNANCY TEST— 510(k) K872730
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K872730 for RESULT PLUS/HCG PREGNANCY TEST, Substantially Equivalent on 1987-10-20. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, 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
- Raritan, NJ, US
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 Ortho Diagnostic Systems, Inc.
view all- K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K963902 — QUANTITATIVE FIBRINOGEN ASSAY
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.