Cleared Traditional

BLUE DOT(TM) TEST FOR PREGNANCY

K882588 · V-Tech, Inc. · Chemistry
Oct 1988
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K882588 is an FDA 510(k) clearance for the BLUE DOT(TM) TEST FOR PREGNANCY, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on October 6, 1988, 105 days after receiving the submission on June 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K882588 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1988
Decision Date October 06, 1988
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

Similar Devices — LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 225
MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test
K251040 · Guangzhou Decheng Biotechnology Co., Ltd. · Sep 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2025
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
K250117 · Assure Tech., LLC · Feb 2025
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
K243573 · Assure Tech., LLC · Jan 2025
iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip
K241394 · Andon Health Co, Ltd. · Dec 2024