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FDA 510(k)

GSP NEONATAL THYROXINE (T4)

K-Number: K103484 · 2011-04-22

ApplicantWallac Oy, A Subsidiary of Perkinelmer, Inc.
Decision Date2011-04-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSP NEONATAL THYROXINE (T4) is the device name listed in this FDA 510(k) record. The listed applicant is Wallac Oy, A Subsidiary of Perkinelmer, Inc.. It received FDA 510(k) clearance on 2011-04-22 under 510(k) number K103484. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSP NEONATAL THYROXINE (T4)?

GSP NEONATAL THYROXINE (T4) is a medical device that received FDA 510(k) clearance on 2011-04-22. The listed applicant is Wallac Oy, A Subsidiary of Perkinelmer, Inc.. The 510(k) number is K103484.

When did GSP NEONATAL THYROXINE (T4) receive FDA 510(k) clearance?

GSP NEONATAL THYROXINE (T4) received FDA 510(k) clearance on 2011-04-22, under 510(k) number K103484.

Who is the listed applicant for GSP NEONATAL THYROXINE (T4)?

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

What is the FDA product code for GSP NEONATAL THYROXINE (T4)?

The FDA product code for GSP NEONATAL THYROXINE (T4) is KLI.

Related Clinical Trials

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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Other records listing Wallac Oy, A Subsidiary of Perkinelmer, 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.

K110274AUTODELFIA NEONATAL IRT KIT

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.K001603REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)Repromedix Corp.

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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