FDA 510(k)

聯盟CMV IgM血清控制組

K 號：K161526 · 2016-06-30

決定日期2016-06-30

產品代碼JJX

諮詢委員會CH

決定相當於

器材摘要

LIAISON CMV IgM Serum Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161526. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON CMV IgM Serum Control Set?

LIAISON CMV IgM Serum Control Set is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161526.

When did LIAISON CMV IgM Serum Control Set receive FDA 510(k) clearance?

LIAISON CMV IgM Serum Control Set received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161526.

Who is the listed applicant for LIAISON CMV IgM Serum Control Set?

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

What is the FDA product code for LIAISON CMV IgM Serum Control Set?

The FDA product code for LIAISON CMV IgM Serum Control Set is JJX.

其他以 DiaSorin, Inc. 為申請人之記錄

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K260770LIAISON Murex HBsAg Qual；LIAISON XL；LIAISON 稀釋X K231214聯繫VZV IgG HT，聯繫控制VZV IgG HT K223403LIAISON 防HAV；LIAISON XS K213858LIAISON 肠蛋白酶，LIAISON Q.S.E.T. 裝置＋K213936LIAISON MeMed BV, LIAISON MeMed BV 控制組 K193650LIAISON 鐵蛋白

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相關器械（代碼：JJX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170678Beta-CrossLaps CalCheck 5Roche Diagnostics K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics K162514多化學A1cTechnopath Manufacturing K161874Audit MicroControls Linearity DROP LQ 血糖檢測儀Aalto Scientific, Ltd.K161522聯盟EBV IgM血清控制組DiaSorin, Inc.K161082IDS-iSYS 17-OH 孕酮控制組，IDS-iSYS 17-OH 孕酮校準驗證器Immunodiagnostic Systems , Ltd.

官方來源

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