LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG— 510(k) K945514
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K945514 for LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG, Substantially Equivalent on 1995-02-10. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code LCX
- 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 allData sourced from openFDA. This site is unofficial and independent of the FDA.