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)

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP

K-Number: K922136 · 1993-08-10

ApplicantHome Diagnostics, Inc.
Decision Date1993-08-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Home Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-08-10 under 510(k) number K922136. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP?

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K922136.

When did ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP receive FDA 510(k) clearance?

ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP received FDA 510(k) clearance on 1993-08-10, under 510(k) number K922136.

Who is the listed applicant for ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP?

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

What is the FDA product code for ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP?

The FDA product code for ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP is CGA.

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 Home Diagnostics, 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.

K090495TRUEBALANCE BLOOD GLUCOSE SYSTEMK080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81K070593TRACKRECORD DATA MANAGEMENT SOFTWAREK060793ELEMENT BLOOD GLUCOSE TEST SYSTEMK051147SIDEKICK BLOOD GLUCOSE TEST SYSTEM

View all 22 devices →

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.

↑