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FDA 510(k)

AFIAS TSH-SP，AFIAS TSH-VB，AFIAS-6/SP分析儀，AFIAS-6/VB分析儀

K 號：K170232 · 2017-10-13

申請人Boditech Med, Inc.
決定日期2017-10-13
產品代碼JLW
諮詢委員會CH
決定相當於

器材摘要

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Boditech Med, Inc.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K170232. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Boditech Med, Inc.. The 510(k) number is K170232.

When did AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer receive FDA 510(k) clearance?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer received FDA 510(k) clearance on 2017-10-13, under 510(k) number K170232.

Who is the listed applicant for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

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

What is the FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

The FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is JLW.

相關臨床試驗

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。

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相關器械（代碼：JLW）

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。

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官方來源

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