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)

CONE-TROL HEMOGLOBIN A1C CONTROL SET

K-Number: K121534 · 2012-06-20

ApplicantCone Bioproducts
Decision Date2012-06-20
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONE-TROL HEMOGLOBIN A1C CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Cone Bioproducts. It received FDA 510(k) clearance on 2012-06-20 under 510(k) number K121534. 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 CONE-TROL HEMOGLOBIN A1C CONTROL SET?

CONE-TROL HEMOGLOBIN A1C CONTROL SET is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Cone Bioproducts. The 510(k) number is K121534.

When did CONE-TROL HEMOGLOBIN A1C CONTROL SET receive FDA 510(k) clearance?

CONE-TROL HEMOGLOBIN A1C CONTROL SET received FDA 510(k) clearance on 2012-06-20, under 510(k) number K121534.

Who is the listed applicant for CONE-TROL HEMOGLOBIN A1C CONTROL SET?

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

What is the FDA product code for CONE-TROL HEMOGLOBIN A1C CONTROL SET?

The FDA product code for CONE-TROL HEMOGLOBIN A1C CONTROL SET 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 Cone Bioproducts 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.

K121759CONE-TROL LIQUID CHEMISTRY CONTROLSK052010HBA1C LINEARITY SET

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.

↑