Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medtest DX. It received FDA 510(k) clearance on 2020-08-11 under 510(k) 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. The listed applicant is Medtest DX. The 510(k) number is K191296.

When did Pointe Scientific Creatinine Kinase (CK) Reagent Set receive FDA 510(k) clearance?

Pointe Scientific Creatinine Kinase (CK) Reagent Set received FDA 510(k) clearance on 2020-08-11, under 510(k) number K191296.

Who is the listed applicant for Pointe Scientific Creatinine Kinase (CK) Reagent Set?

The FDA 510(k) record lists Medtest DX as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medtest DX 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.

K191638Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

Related Devices (Code: CGS)

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.

K182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, 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.

↑