FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST— 510(k) K123567
Substantially EquivalentChurch & Dwight Co., Inc.
FDA 510(k) clearance K123567 for FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST, Substantially Equivalent on 2013-09-10. Applicant: Church & Dwight Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Church & Dwight Co., Inc.
- 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.