PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG— 510(k) K926356
Substantially EquivalentBecton Dickinson Advanced Diagnostics
FDA 510(k) clearance K926356 for PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG, Substantially Equivalent on 1993-03-18. Applicant: Becton Dickinson Advanced Diagnostics. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Advanced Diagnostics
- 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
- Sparks, MD, 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 Becton Dickinson Advanced Diagnostics
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.