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)

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM

K-Number: K955042 · 1995-12-13

ApplicantShared Systems, Inc.
Decision Date1995-12-13
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shared Systems, Inc.. It received FDA 510(k) clearance on 1995-12-13 under 510(k) number K955042. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM?

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Shared Systems, Inc.. The 510(k) number is K955042.

When did CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM receive FDA 510(k) clearance?

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM received FDA 510(k) clearance on 1995-12-13, under 510(k) number K955042.

Who is the listed applicant for CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM?

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

What is the FDA product code for CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM?

The FDA product code for CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM is DCN.

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 Shared Systems, 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.

K973457CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800K950073MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMK953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEMK920212MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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.

↑