FDA 510(k)

PTS專業化學套件

K 號：K182781 · 2018-12-21

申請人Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

決定日期2018-12-21

產品代碼CGA

諮詢委員會CH

決定Unknown

器材摘要

PTS Professional Chemistry Kit is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182781. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

常見問題

What is the PTS Professional Chemistry Kit?

PTS Professional Chemistry Kit is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K182781.

When did PTS Professional Chemistry Kit receive FDA 510(k) clearance?

PTS Professional Chemistry Kit received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182781.

Who is the listed applicant for PTS Professional Chemistry Kit?

The FDA 510(k) record lists Polymer Technology Systems, Inc. D/B/A Pts Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTS Professional Chemistry Kit?

The FDA product code for PTS Professional Chemistry Kit is CGA.

其他以 Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 為申請人之記錄

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相關器械（代碼：CGA）

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