CRC-77tHR
K-Number: K162394 · 2017-03-08
ApplicantCapintec, Inc.
Decision Date2017-03-08
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CRC-77tHR is a medical device manufactured by Capintec, Inc.. It received FDA 510(k) clearance on 2017-03-08 under approval number K162394. 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-77tHR?
CRC-77tHR is a medical device that received FDA 510(k) clearance on 2017-03-08. It is manufactured by Capintec, Inc.. The 510(k) number is K162394.
When was CRC-77tHR approved by the FDA?
CRC-77tHR received FDA 510(k) clearance on 2017-03-08, under approval number K162394.
What company makes CRC-77tHR?
CRC-77tHR is manufactured by Capintec, Inc..
What is the FDA product code for CRC-77tHR?
The FDA product code for CRC-77tHR 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.