BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
FDA 510(k) clearance K944426 · decided 1994-10-25
Clearance details
- K-number
- K944426
- Device name
- BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-12
- Decision date
- 1994-10-25
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorioni recall (Z-0259-2025) | Princeton Biomeditech Corp | 2024-10-30 |