GSP新生兒全乳糖套件
K 號：K190335 · 2019-11-06
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器材摘要
GSP Neonatal Total Galactose 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 2019-11-06 under 510(k) number K190335. The device is classified under product code JIA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GSP Neonatal Total Galactose kit?
GSP Neonatal Total Galactose kit is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190335.
When did GSP Neonatal Total Galactose kit receive FDA 510(k) clearance?
GSP Neonatal Total Galactose kit received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190335.
Who is the listed applicant for GSP Neonatal Total Galactose 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 Neonatal Total Galactose kit?
The FDA product code for GSP Neonatal Total Galactose kit is JIA.
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其他以 Perkinelmer, Inc. 為申請人之記錄
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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