FIRST RESPONSE EARLY RESULT PREGNANCY TEST— 510(k) K123436
Substantially EquivalentChurch & Dwight Co., Inc.
FDA 510(k) clearance K123436 for FIRST RESPONSE EARLY RESULT PREGNANCY TEST, Substantially Equivalent on 2013-08-26. 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
Recent devices under product code LCX
view all- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
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- K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
- K203818 — Replens Long-Lasting Vaginal Moisturizer
Recalls naming K123436
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123436.
Data sourced from openFDA. This site is unofficial and independent of the FDA.