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FDA 510(k)

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)

K-Number: K861703 · 1986-07-29

ApplicantLeeco Diagnostics, Inc.
Decision Date1986-07-29
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) 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 1986-07-29 under 510(k) number K861703. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)?

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K861703.

When did LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) receive FDA 510(k) clearance?

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) received FDA 510(k) clearance on 1986-07-29, under 510(k) number K861703.

Who is the listed applicant for LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)?

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 LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)?

The FDA product code for LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) is JHJ.

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

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Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.

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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