CRC-77tHR
K 號：K162394 · 2017-03-08
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器材摘要
CRC-77tHR is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K162394. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the CRC-77tHR?
CRC-77tHR is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Capintec, Inc.. The 510(k) number is K162394.
When did CRC-77tHR receive FDA 510(k) clearance?
CRC-77tHR received FDA 510(k) clearance on 2017-03-08, under 510(k) number K162394.
Who is the listed applicant for CRC-77tHR?
The FDA 510(k) record lists Capintec, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CRC-77tHR?
The FDA product code for CRC-77tHR is KPT. This falls under the In Vitro Diagnostics category.
其他以 Capintec, Inc. 為申請人之記錄
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相關器械（代碼：KPT）
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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