BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES— 510(k) K962183
Substantially EquivalentArmkel, LLC
FDA 510(k) clearance K962183 for BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES, Substantially Equivalent on 1996-07-10. 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
- Cranbury, NJ, US
Recent devices under product code LCX
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- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
More clearances from Armkel, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.