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)

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER

K-Number: K050100 · 2005-02-25

ApplicantBionostics, Inc.
Decision Date2005-02-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2005-02-25 under 510(k) number K050100. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER?

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER is a medical device that received FDA 510(k) clearance on 2005-02-25. The listed applicant is Bionostics, Inc.. The 510(k) number is K050100.

When did RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER receive FDA 510(k) clearance?

RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER received FDA 510(k) clearance on 2005-02-25, under 510(k) number K050100.

Who is the listed applicant for RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER?

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

What is the FDA product code for RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER?

The FDA product code for RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER is JJX.

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 Bionostics, Inc. 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.

K131136GLUCOSE METER-CHECK SOLUTION FOR TAIDOCK123851GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEKK123966GLUCOSE METER-CHECK SOLUTION FOR BAYERK113764GLUCOSE METER-CHECK SOLUTION FOR INFOPIAK112352GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTK112356GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

View all 49 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑