FDA 510(k)

Quantisal™ 口腔液收集器

K 號：K232898 · 2023-11-21

決定日期2023-11-21

產品代碼PJD

諮詢委員會CH

決定相當於

器材摘要

Quantisal™ Oral Fluid Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232898. The device is classified under product code PJD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantisal™ Oral Fluid Collection Device?

Quantisal™ Oral Fluid Collection Device is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Immunalysis Corporation. The 510(k) number is K232898.

When did Quantisal™ Oral Fluid Collection Device receive FDA 510(k) clearance?

Quantisal™ Oral Fluid Collection Device received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232898.

Who is the listed applicant for Quantisal™ Oral Fluid Collection Device?

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

What is the FDA product code for Quantisal™ Oral Fluid Collection Device?

The FDA product code for Quantisal™ Oral Fluid Collection Device is PJD.

其他以 Immunalysis Corporation 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。

K252520SEFRIA™ Hydrocodone 口服濃縮液 K223781Quantisal™ II 口腔液收集器 K203564SEFRIA 口服氧鴉片濾液酶免疫分析 K203647SEFRIA甲基安非他命口腔液酶免疫測試 K203489SEFRIA PCP 口腔濾液酶免疫分析 K200801Quantisal 口腔液收集器

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相關器械（代碼：PJD）

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。

K223781Quantisal™ II 口腔液收集器Immunalysis Corporation K200801Quantisal 口腔液收集器Immunalysis Corporation K183048Quantisal II 口腔液收集器Immunalysis Corporation

官方來源

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