ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST— 510(k) K030533
Substantially EquivalentCenogenics Corp.
FDA 510(k) clearance K030533 for ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST, Substantially Equivalent on 2003-04-17. Applicant: Cenogenics Corp.. Device class: 2.
Clearance details
- Applicant
- Cenogenics 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
- Morganville, NJ, US
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More clearances from Cenogenics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.