Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
K-Number: K180607 · 2018-11-23
ApplicantKronus, Inc.
Decision Date2018-11-23
Product CodePCG
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is a medical device manufactured by Kronus, Inc.. It received FDA 510(k) clearance on 2018-11-23 under approval number K180607. The device is classified under product code PCG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is a medical device that received FDA 510(k) clearance on 2018-11-23. It is manufactured by Kronus, Inc.. The 510(k) number is K180607.
When was Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit approved by the FDA?
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit received FDA 510(k) clearance on 2018-11-23, under approval number K180607.
What company makes Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is manufactured by Kronus, Inc..
What is the FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?
The FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is PCG.
Other Devices by Kronus, Inc.
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.