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)

LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS

K-Number: K971014 · 1997-04-23

ApplicantLifescan, Inc.
Decision Date1997-04-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K971014. 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 LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS?

LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Lifescan, Inc.. The 510(k) number is K971014.

When did LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS receive FDA 510(k) clearance?

LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS received FDA 510(k) clearance on 1997-04-23, under 510(k) number K971014.

Who is the listed applicant for LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS?

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

What is the FDA product code for LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS?

The FDA product code for LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS 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 Lifescan, 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.

K132618ONETOUCH REVEALK120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONK093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMK082590SYMPHONY METER REMOTEK082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMK081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

View all 42 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.

↑