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FDA 510(k)

VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042

K-Number: K863999 · 1987-01-09

ApplicantLeeco Diagnostics, Inc.
Decision Date1987-01-09
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K863999. 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 VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042?

VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K863999.

When did VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 receive FDA 510(k) clearance?

VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 received FDA 510(k) clearance on 1987-01-09, under 510(k) number K863999.

Who is the listed applicant for VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042?

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

What is the FDA product code for VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042?

The FDA product code for VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 is LCX.

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Other records listing Leeco Diagnostics, 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.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891096VIS-DISK HCG (EIA) JPL-041MK891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK883269PRL-QUANTK880577CONCEP-7-BHCG

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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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