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FDA 510(k)

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY

K-Number: K923532 · 1993-03-12

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1993-03-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare Technologies Corp,Inc.. It received FDA 510(k) clearance on 1993-03-12 under 510(k) number K923532. 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 NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY?

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY is a medical device that received FDA 510(k) clearance on 1993-03-12. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K923532.

When did NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY receive FDA 510(k) clearance?

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY received FDA 510(k) clearance on 1993-03-12, under 510(k) number K923532.

Who is the listed applicant for NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY?

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

What is the FDA product code for NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY?

The FDA product code for NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY is JLW.

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Related Devices (Code: JLW)

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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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