FDA 510(k)

CRC PC Smart 室腔 K1

K号: K192199 · 2019-09-12

决定日期2019-09-12

产品代码KPT

咨询委员会RA

决定实质等同

器械摘要

CRC PC Smart Chamber K1 is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K192199. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the CRC PC Smart Chamber K1?

CRC PC Smart Chamber K1 is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Capintec, Inc.. The 510(k) number is K192199.

When did CRC PC Smart Chamber K1 receive FDA 510(k) clearance?

CRC PC Smart Chamber K1 received FDA 510(k) clearance on 2019-09-12, under 510(k) number K192199.

Who is the listed applicant for CRC PC Smart Chamber K1?

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

What is the FDA product code for CRC PC Smart Chamber K1?

The FDA product code for CRC PC Smart Chamber K1 is KPT. This falls under the In Vitro Diagnostics category.

列明Capintec, Inc.为申报人的其他记录

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