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)

KINETIC CREATININE

K-Number: K830447 · 1983-03-24

ApplicantAmerican Monitor Corp.
Decision Date1983-03-24
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KINETIC CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830447. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINETIC CREATININE?

KINETIC CREATININE is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is American Monitor Corp.. The 510(k) number is K830447.

When did KINETIC CREATININE receive FDA 510(k) clearance?

KINETIC CREATININE received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830447.

Who is the listed applicant for KINETIC CREATININE?

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

What is the FDA product code for KINETIC CREATININE?

The FDA product code for KINETIC CREATININE is CGX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

View all 73 devices →

Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens 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.

↑