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FDA 510(k)

V-TREND TARGET CRP TEST

K-Number: K892231 · 1989-04-21

ApplicantTexas Immunology, Inc.
Decision Date1989-04-21
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

V-TREND TARGET CRP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K892231. 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 V-TREND TARGET CRP TEST?

V-TREND TARGET CRP TEST is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K892231.

When did V-TREND TARGET CRP TEST receive FDA 510(k) clearance?

V-TREND TARGET CRP TEST received FDA 510(k) clearance on 1989-04-21, under 510(k) number K892231.

Who is the listed applicant for V-TREND TARGET CRP TEST?

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

What is the FDA product code for V-TREND TARGET CRP TEST?

The FDA product code for V-TREND TARGET CRP TEST is DCN.

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Other records listing Texas Immunology, 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.

K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK972094TARGET CARDIAC TROPONIN I TESTK963680TARGET MYOGLOBIN TESTK912246TARGET MICROALBUMINURIA 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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