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FDA 510(k)

VIS-CUBE HCG (EIA)

K-Number: K863933 · 1986-12-15

ApplicantLeeco Diagnostics, Inc.
Decision Date1986-12-15
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIS-CUBE HCG (EIA) 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 1986-12-15 under 510(k) number K863933. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIS-CUBE HCG (EIA)?

VIS-CUBE HCG (EIA) is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K863933.

When did VIS-CUBE HCG (EIA) receive FDA 510(k) clearance?

VIS-CUBE HCG (EIA) received FDA 510(k) clearance on 1986-12-15, under 510(k) number K863933.

Who is the listed applicant for VIS-CUBE HCG (EIA)?

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 HCG (EIA)?

The FDA product code for VIS-CUBE HCG (EIA) is JHI.

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)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCG

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Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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