FDA 510(k)

免疫分析卡瑞索普多醇代謝物/美普洛馬特尿液HEIA

K 號：K190397 · 2019-11-15

決定日期2019-11-15

產品代碼QBK

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

決定相當於

器材摘要

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K190397. The device is classified under product code QBK. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Immunalysis Corporation. The 510(k) number is K190397.

When did Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA receive FDA 510(k) clearance?

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA received FDA 510(k) clearance on 2019-11-15, under 510(k) number K190397.

Who is the listed applicant for Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

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 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA?

The FDA product code for Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is QBK.

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 K232898Quantisal™ 口腔液收集器 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

查看所有 15 項裝置 →

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。