ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA— 510(k) K981801
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K981801 for ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA, Substantially Equivalent on 1998-08-25. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code LFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3910
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
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