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FDA 510(k)

CPR SLIDE EIKEN

K-Number: K854819 · 1986-02-26

ApplicantSyn-Kit, Inc.
Decision Date1986-02-26
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CPR SLIDE EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1986-02-26 under 510(k) number K854819. 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 CPR SLIDE EIKEN?

CPR SLIDE EIKEN is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K854819.

When did CPR SLIDE EIKEN receive FDA 510(k) clearance?

CPR SLIDE EIKEN received FDA 510(k) clearance on 1986-02-26, under 510(k) number K854819.

Who is the listed applicant for CPR SLIDE EIKEN?

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

What is the FDA product code for CPR SLIDE EIKEN?

The FDA product code for CPR SLIDE EIKEN is DCN.

Related Clinical Trials

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GKK843753UROPAPER EIKEN GP

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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.

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