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FDA 510(k)

MIDSTREAM ONESTEP PREGNANCY HOME TEST

K-Number: K963341 · 1996-12-02

ApplicantSyntron Bioresearch, Inc.
Decision Date1996-12-02
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MIDSTREAM ONESTEP PREGNANCY HOME TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1996-12-02 under 510(k) number K963341. 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 MIDSTREAM ONESTEP PREGNANCY HOME TEST?

MIDSTREAM ONESTEP PREGNANCY HOME TEST is a medical device that received FDA 510(k) clearance on 1996-12-02. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K963341.

When did MIDSTREAM ONESTEP PREGNANCY HOME TEST receive FDA 510(k) clearance?

MIDSTREAM ONESTEP PREGNANCY HOME TEST received FDA 510(k) clearance on 1996-12-02, under 510(k) number K963341.

Who is the listed applicant for MIDSTREAM ONESTEP PREGNANCY HOME TEST?

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

What is the FDA product code for MIDSTREAM ONESTEP PREGNANCY HOME TEST?

The FDA product code for MIDSTREAM ONESTEP PREGNANCY HOME TEST is LCX.

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Other records listing Syntron Bioresearch, 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.

K993490QUICKSTRIP ONE STEP OPIATES TESTK993491QUICKPAC II ONE STEP OPIATES TESTK992990QUICKPAC II ONE STEP COCAINE TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

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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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