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)

HICHEM ISE DILUENT KIT 70008

K-Number: K953860 · 1995-09-06

ApplicantHichem Diagnostics
Decision Date1995-09-06
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ISE DILUENT KIT 70008 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1995-09-06 under 510(k) number K953860. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM ISE DILUENT KIT 70008?

HICHEM ISE DILUENT KIT 70008 is a medical device that received FDA 510(k) clearance on 1995-09-06. The listed applicant is Hichem Diagnostics. The 510(k) number is K953860.

When did HICHEM ISE DILUENT KIT 70008 receive FDA 510(k) clearance?

HICHEM ISE DILUENT KIT 70008 received FDA 510(k) clearance on 1995-09-06, under 510(k) number K953860.

Who is the listed applicant for HICHEM ISE DILUENT KIT 70008?

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 HICHEM ISE DILUENT KIT 70008?

The FDA product code for HICHEM ISE DILUENT KIT 70008 is CGZ.

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 KITK953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953862HICHEM ISEKCI SOLUTION KIT 70010K953863HICHEM ISE STANDARDS KIT 70011K951751HICHEM AST REAGENT KIT

View all 41 devices →

Related Devices (Code: CGZ)

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.

K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT Sample DiluentAbbott LaboratoriesK162020VITROS Chemistry Products Cl- SlidesOrtho Clinical DiagnosticsK082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905Ortho-Clinical Diagnostics, Inc.K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112Wallac OYK070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher Scientific

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.

↑