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FDA 510(k)

NABI CRP-Q.S. TEST

K-Number: K834584 · 1984-02-27

ApplicantIntl. Diagnostic, Inc.
Decision Date1984-02-27
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NABI CRP-Q.S. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K834584. 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 NABI CRP-Q.S. TEST?

NABI CRP-Q.S. TEST is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K834584.

When did NABI CRP-Q.S. TEST receive FDA 510(k) clearance?

NABI CRP-Q.S. TEST received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834584.

Who is the listed applicant for NABI CRP-Q.S. TEST?

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

What is the FDA product code for NABI CRP-Q.S. TEST?

The FDA product code for NABI CRP-Q.S. TEST is DCN.

Other records listing Intl. Diagnostic, 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.

K841853PREG-BETA ONE HOUR TUBE TESTK840833PREG BETA BLUS SLIDEK840005NABI RF-Q.S. TESTK802343PREGNA B-ANTI HUMAN CHORIONIC GONADOTROK780321PREGNANCY TEST KIT, OVER-THE-COUNTER

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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