FDA 510(k)

快速毒杯II

K 號：K170222 · 2017-08-15

決定日期2017-08-15

產品代碼LAF

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決定相當於

器材摘要

Rapid Tox Cup II is the device name listed in this FDA 510(k) record. The listed applicant is American Bio Medica Corp.. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K170222. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid Tox Cup II?

Rapid Tox Cup II is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is American Bio Medica Corp.. The 510(k) number is K170222.

When did Rapid Tox Cup II receive FDA 510(k) clearance?

Rapid Tox Cup II received FDA 510(k) clearance on 2017-08-15, under 510(k) number K170222.

Who is the listed applicant for Rapid Tox Cup II?

The FDA 510(k) record lists American Bio Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Tox Cup II?

The FDA product code for Rapid Tox Cup II is LAF.

相關器械（代碼：LAF）

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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