BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT— 510(k) K954065
Substantially EquivalentBiochem Immunosystems (U.S.), Inc.
FDA 510(k) clearance K954065 for BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1996-07-10. Applicant: Biochem Immunosystems (U.S.), Inc.. Device class: 2.
Clearance details
- Applicant
- Biochem Immunosystems (U.S.), 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
- Allentown, PA, US
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More clearances from Biochem Immunosystems (U.S.), 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.