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FDA 510(k)

EYE SPOT CRP TEST

K-Number: K932180 · 1993-08-23

ApplicantJ.S. Medical Assoc.
Decision Date1993-08-23
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EYE SPOT CRP TEST is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1993-08-23 under 510(k) number K932180. 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 EYE SPOT CRP TEST?

EYE SPOT CRP TEST is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K932180.

When did EYE SPOT CRP TEST receive FDA 510(k) clearance?

EYE SPOT CRP TEST received FDA 510(k) clearance on 1993-08-23, under 510(k) number K932180.

Who is the listed applicant for EYE SPOT CRP TEST?

The FDA 510(k) record lists J.S. Medical Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE SPOT CRP TEST?

The FDA product code for EYE SPOT CRP TEST is DCN.

Other records listing J.S. Medical Assoc. 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.

K932752VISI-SPOTK932688EYE SPOT IM TESTK932551ACCUTEX IM LATEX TESTK926112ACCUTEX BETA-HCG TESTK924332ACCUTEX CRP LATEX TESTK924247ACCUTEX ASO LATEX TEST

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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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