ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT— 510(k) K955266
Substantially EquivalentBoehringer Mannheim Italia Spa
FDA 510(k) clearance K955266 for ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT, Substantially Equivalent on 1996-02-29. Applicant: Boehringer Mannheim Italia Spa. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Italia Spa
- 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
- Simi Valley, CA, US
Recent devices under product code JHI
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- 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 Boehringer Mannheim Italia Spa
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.