FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST— 510(k) K040866
Substantially EquivalentArmkel, LLC
FDA 510(k) clearance K040866 for FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST, Substantially Equivalent on 2004-10-19. Applicant: Armkel, LLC. Device class: 2.
Clearance details
- Applicant
- Armkel, LLC
- 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
- Princeton, NJ, US
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More clearances from Armkel, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.