VISUALINE II HCG— 510(k) K943239
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K943239 for VISUALINE II HCG, Substantially Equivalent on 1994-12-07. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Biomedical Laboratories, 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
- Cherry Hill, 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 Sun Biomedical Laboratories, Inc.
view all- K023856 — VISUALINE METHADONE DIPSTRIPTEST
- K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
- K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
- K020136 — VISUALINE BARBITURATES DIPSTRIP TEST
- K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY
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.