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FDA 510(k)

CONCEP-7-BHCG

K-Number: K792308 · 1979-12-06

ApplicantLeeco Diagnostics, Inc.
Decision Date1979-12-06
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONCEP-7-BHCG 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 1979-12-06 under 510(k) number K792308. 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 CONCEP-7-BHCG?

CONCEP-7-BHCG is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K792308.

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

CONCEP-7-BHCG received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792308.

Who is the listed applicant for CONCEP-7-BHCG?

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 CONCEP-7-BHCG?

The FDA product code for CONCEP-7-BHCG 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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