VISUALINE D HCG— 510(k) K963408
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K963408 for VISUALINE D HCG, Substantially Equivalent on 1996-10-18. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Biomedical Laboratories, 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
- Cherry Hill, NJ, US
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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.