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FDA 510(k)

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

K-Number: K090846 · 2009-09-03

ApplicantPerkinelmer, Inc.
Decision Date2009-09-03
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K090846. 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 GSP INSTRUMENT AND GSP NEONATAL HTSH KIT?

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K090846.

When did GSP INSTRUMENT AND GSP NEONATAL HTSH KIT receive FDA 510(k) clearance?

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT received FDA 510(k) clearance on 2009-09-03, under 510(k) number K090846.

Who is the listed applicant for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT?

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

What is the FDA product code for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT?

The FDA product code for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT 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

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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