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FDA 510(k)

LEECO T3% DIAGNOSTIC KIT

K-Number: K822575 · 1982-09-30

ApplicantLeeco Diagnostics, Inc.
Decision Date1982-09-30
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO T3% DIAGNOSTIC KIT 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 1982-09-30 under 510(k) number K822575. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO T3% DIAGNOSTIC KIT?

LEECO T3% DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K822575.

When did LEECO T3% DIAGNOSTIC KIT receive FDA 510(k) clearance?

LEECO T3% DIAGNOSTIC KIT received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822575.

Who is the listed applicant for LEECO T3% DIAGNOSTIC KIT?

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 T3% DIAGNOSTIC KIT?

The FDA product code for LEECO T3% DIAGNOSTIC KIT is KHQ.

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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: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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