Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems — FDA 510(k) K153651

医療機器の概要

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K153651. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K153651.

When did Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems receive FDA 510(k) clearance?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems received FDA 510(k) clearance on 2016-08-18, under 510(k) number K153651.

Who is the listed applicant for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

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

What is the FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

The FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is JLW.

申請者としてBeckman Coulter, Inc.を記載するその他の記録

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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すべての73件のデバイスを表示 →

関連機器（コード：JLW）

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

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 Diagnostics K234091Maverick 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.

公式ソース

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