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FDA 510(k)

LEECO CONCEP-7-BHCG LEIAD II

K-Number: K850201 · 1985-03-04

ApplicantLeeco Diagnostics, Inc.
Decision Date1985-03-04
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO CONCEP-7-BHCG LEIAD II 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 1985-03-04 under 510(k) number K850201. 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 LEECO CONCEP-7-BHCG LEIAD II?

LEECO CONCEP-7-BHCG LEIAD II is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K850201.

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

LEECO CONCEP-7-BHCG LEIAD II received FDA 510(k) clearance on 1985-03-04, under 510(k) number K850201.

Who is the listed applicant for LEECO CONCEP-7-BHCG LEIAD II?

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 LEIAD II?

The FDA product code for LEECO CONCEP-7-BHCG LEIAD II is JHI.

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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: 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.

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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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