CRC PC Smart Chamber K1
K-Number: K192199 · 2019-09-12
ApplicantCapintec, Inc.
Decision Date2019-09-12
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CRC PC Smart Chamber K1 is a medical device manufactured by Capintec, Inc.. It received FDA 510(k) clearance on 2019-09-12 under approval 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. It is manufactured by Capintec, Inc.. The 510(k) number is K192199.
When was CRC PC Smart Chamber K1 approved by the FDA?
CRC PC Smart Chamber K1 received FDA 510(k) clearance on 2019-09-12, under approval number K192199.
What company makes CRC PC Smart Chamber K1?
CRC PC Smart Chamber K1 is manufactured by Capintec, Inc..
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 Devices by Capintec, Inc.
Related Devices (Code: KPT)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.