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FDA 510(k)

SAS HCG-CHECK

K-Number: K991193 · 1999-05-04

ApplicantSa Scientific, Inc.
Decision Date1999-05-04
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAS HCG-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific, Inc.. It received FDA 510(k) clearance on 1999-05-04 under 510(k) number K991193. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS HCG-CHECK?

SAS HCG-CHECK is a medical device that received FDA 510(k) clearance on 1999-05-04. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K991193.

When did SAS HCG-CHECK receive FDA 510(k) clearance?

SAS HCG-CHECK received FDA 510(k) clearance on 1999-05-04, under 510(k) number K991193.

Who is the listed applicant for SAS HCG-CHECK?

The FDA 510(k) record lists Sa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAS HCG-CHECK?

The FDA product code for SAS HCG-CHECK is LCX.

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Other records listing Sa Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTK080380SAS INFLUENZA A & B TESTK041439SAS INFLUENZA B TESTK041441SAS INFLUENZA A TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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