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FDA 510(k)

EMIT C-REACTIVE PROTEIN ASSAY

K-Number: K821413 · 1982-05-28

ApplicantSyva Co.
Decision Date1982-05-28
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EMIT C-REACTIVE PROTEIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821413. 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 EMIT C-REACTIVE PROTEIN ASSAY?

EMIT C-REACTIVE PROTEIN ASSAY is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Syva Co.. The 510(k) number is K821413.

When did EMIT C-REACTIVE PROTEIN ASSAY receive FDA 510(k) clearance?

EMIT C-REACTIVE PROTEIN ASSAY received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821413.

Who is the listed applicant for EMIT C-REACTIVE PROTEIN ASSAY?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMIT C-REACTIVE PROTEIN ASSAY?

The FDA product code for EMIT C-REACTIVE PROTEIN ASSAY is DCN.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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