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FDA 510(k)

PTK HEALTHCHECK PREGNANCY TEST KIT

K-Number: K844281 · 1984-12-10

ApplicantHealthcheck Corp.
Decision Date1984-12-10
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTK HEALTHCHECK PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Healthcheck Corp.. It received FDA 510(k) clearance on 1984-12-10 under 510(k) number K844281. 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 PTK HEALTHCHECK PREGNANCY TEST KIT?

PTK HEALTHCHECK PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-12-10. The listed applicant is Healthcheck Corp.. The 510(k) number is K844281.

When did PTK HEALTHCHECK PREGNANCY TEST KIT receive FDA 510(k) clearance?

PTK HEALTHCHECK PREGNANCY TEST KIT received FDA 510(k) clearance on 1984-12-10, under 510(k) number K844281.

Who is the listed applicant for PTK HEALTHCHECK PREGNANCY TEST KIT?

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

What is the FDA product code for PTK HEALTHCHECK PREGNANCY TEST KIT?

The FDA product code for PTK HEALTHCHECK PREGNANCY TEST KIT is LCX.

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Other records listing Healthcheck Corp. 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.

K884489C&T PREGNANCY TEST KITK874818TENSTARK881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1K863181HEALTHCHECK THERM-STRIPK861946PTK PLUS. HOME PREGNANCY TESTK860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3

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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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