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FDA 510(k)

BI-CRP LATEX TEST

K-Number: K811374 · 1981-06-12

ApplicantBiologics Intl., Inc.
Decision Date1981-06-12
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BI-CRP LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811374. 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 BI-CRP LATEX TEST?

BI-CRP LATEX TEST is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K811374.

When did BI-CRP LATEX TEST receive FDA 510(k) clearance?

BI-CRP LATEX TEST received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811374.

Who is the listed applicant for BI-CRP LATEX TEST?

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

What is the FDA product code for BI-CRP LATEX TEST?

The FDA product code for BI-CRP LATEX TEST is DCN.

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Other records listing Biologics Intl., 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.

K882229AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMSK823353CARCINO-CEKK812060BI-ASO SLIDE TESTK811375BI-RA SLIDE TESTK800605ANA LATEX SLIDE TESTK791609BE-SURE

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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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