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)

RAICHEM MULTI-ANALYTE CALIBRATOR

K-Number: K012250 · 2001-09-24

ApplicantHemagen Diagnostics, Inc.
Decision Date2001-09-24
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM MULTI-ANALYTE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-09-24 under 510(k) number K012250. 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 RAICHEM MULTI-ANALYTE CALIBRATOR?

RAICHEM MULTI-ANALYTE CALIBRATOR is a medical device that received FDA 510(k) clearance on 2001-09-24. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K012250.

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

RAICHEM MULTI-ANALYTE CALIBRATOR received FDA 510(k) clearance on 2001-09-24, under 510(k) number K012250.

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

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

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

The FDA product code for RAICHEM MULTI-ANALYTE 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 Hemagen 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.

K041051RAICHEM BUN RATE REAGENT (LIQUID)K041052RAICHEM GLUCOSE UV (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

View all 52 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.

↑