FDA 510(k)

細菌內毒素活性測試 (EAA)

K 號：K183176 · 2019-03-12

決定日期2019-03-12

產品代碼NGS

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Endotoxin Activity Assay (EAA) is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183176. The device is classified under product code NGS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endotoxin Activity Assay (EAA)?

Endotoxin Activity Assay (EAA) is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K183176.

When did Endotoxin Activity Assay (EAA) receive FDA 510(k) clearance?

Endotoxin Activity Assay (EAA) received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183176.

Who is the listed applicant for Endotoxin Activity Assay (EAA)?

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

What is the FDA product code for Endotoxin Activity Assay (EAA)?

The FDA product code for Endotoxin Activity Assay (EAA) is NGS.

其他以 Spectral Medical, Inc. 為申請人之記錄

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K170790SAM CRRT 計劃，SAM 盒式 CRRT

官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 Spectral Medical, Inc. 為申請人之記錄

官方來源