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)

MULTI-ANALYTE CHEMISTRY CALIBRATOR

K-Number: K070207 · 2007-04-13

ApplicantPointe Scientific, Inc.,
Decision Date2007-04-13
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTI-ANALYTE CHEMISTRY CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070207. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-ANALYTE CHEMISTRY CALIBRATOR?

MULTI-ANALYTE CHEMISTRY CALIBRATOR is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K070207.

When did MULTI-ANALYTE CHEMISTRY CALIBRATOR receive FDA 510(k) clearance?

MULTI-ANALYTE CHEMISTRY CALIBRATOR received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070207.

Who is the listed applicant for MULTI-ANALYTE CHEMISTRY CALIBRATOR?

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

What is the FDA product code for MULTI-ANALYTE CHEMISTRY CALIBRATOR?

The FDA product code for MULTI-ANALYTE CHEMISTRY CALIBRATOR is JIX.

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 Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSK051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

View all 74 devices →

Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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.

↑