Pointe Scientific Creatinine Kinase (CK) Reagent Set
K-Number: K191296 · 2020-08-11
ApplicantMedtest DX
Decision Date2020-08-11
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Pointe Scientific Creatinine Kinase (CK) Reagent Set is a medical device manufactured by Medtest DX. It received FDA 510(k) clearance on 2020-08-11 under approval number K191296. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pointe Scientific Creatinine Kinase (CK) Reagent Set?
Pointe Scientific Creatinine Kinase (CK) Reagent Set is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Medtest DX. The 510(k) number is K191296.
When was Pointe Scientific Creatinine Kinase (CK) Reagent Set approved by the FDA?
Pointe Scientific Creatinine Kinase (CK) Reagent Set received FDA 510(k) clearance on 2020-08-11, under approval number K191296.
What company makes Pointe Scientific Creatinine Kinase (CK) Reagent Set?
Pointe Scientific Creatinine Kinase (CK) Reagent Set is manufactured by Medtest DX.
What is the FDA product code for Pointe Scientific Creatinine Kinase (CK) Reagent Set?
The FDA product code for Pointe Scientific Creatinine Kinase (CK) Reagent Set is CGS.
Other Devices by Medtest DX
Related Devices (Code: CGS)
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.