BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE— 510(k) K944426
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K944426 for BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE, Substantially Equivalent on 1994-10-25. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- 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
- Monmouth Junction, NJ, US
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More clearances from Princeton BioMeditech Corp.
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 →
Recalls naming K944426
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944426.
Data sourced from openFDA. This site is unofficial and independent of the FDA.