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FDA 510(k)

LEE-BEAD TSH(EIA)

K-Number: K852224 · 1985-07-09

ApplicantLecco Diagnostics, Inc.
Decision Date1985-07-09
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEE-BEAD TSH(EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Lecco Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852224. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEE-BEAD TSH(EIA)?

LEE-BEAD TSH(EIA) is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Lecco Diagnostics, Inc.. The 510(k) number is K852224.

When did LEE-BEAD TSH(EIA) receive FDA 510(k) clearance?

LEE-BEAD TSH(EIA) received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852224.

Who is the listed applicant for LEE-BEAD TSH(EIA)?

The FDA 510(k) record lists Lecco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEE-BEAD TSH(EIA)?

The FDA product code for LEE-BEAD TSH(EIA) is JLW.

Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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