FDA 510(k)

CRC PC Smart Chamber K1

K-Number: K192199 · 2019-09-12

Decision Date2019-09-12

Product CodeKPT

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Capintec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162394CRC-77tHR

Related Devices (Code: KPT)

K162394CRC-77tHRCapintec, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.