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)

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL

K-Number: K913792 · 1991-09-25

ApplicantHichem Diagnostics
Decision Date1991-09-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913792. 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 HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL?

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Hichem Diagnostics. The 510(k) number is K913792.

When did HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL receive FDA 510(k) clearance?

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913792.

Who is the listed applicant for HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL?

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

What is the FDA product code for HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL?

The FDA product code for HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL 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 Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011K953862HICHEM ISEKCI SOLUTION KIT 70010

View all 41 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.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.K161526LIAISON CMV 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.

↑