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FDA 510(k)

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

K-Number: K032159 · 2003-09-05

ApplicantAccess Bio Incorporate
Decision Date2003-09-05
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio Incorporate. It received FDA 510(k) clearance on 2003-09-05 under 510(k) number K032159. 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 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY?

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Access Bio Incorporate. The 510(k) number is K032159.

When did CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY receive FDA 510(k) clearance?

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY received FDA 510(k) clearance on 2003-09-05, under 510(k) number K032159.

Who is the listed applicant for CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY?

The FDA 510(k) record lists Access Bio Incorporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY?

The FDA product code for CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY is LCX.

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Other records listing Access Bio Incorporate 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.

K051925CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBINK031048CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TESTK031052CARESTART HCG ONE-STEP PREGNANCY TEST

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

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

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