Cleared Traditional

SAS HCG-CHECK

K991193 · Sa Scientific, Inc. · Chemistry
May 1999
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K991193 is an FDA 510(k) clearance for the SAS HCG-CHECK, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 4, 1999, 26 days after receiving the submission on April 8, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K991193 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1999
Decision Date May 04, 1999
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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