ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B— 510(k) K974181
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K974181 for ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B, Substantially Equivalent on 1997-12-11. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code JXM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3170
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monmouth Junction, NJ, US
Recent devices under product code JXM
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