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FDA 510(k)

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)

K-Number: K042485 · 2004-10-29

ApplicantRoche Diagnostics Corp.
Decision Date2004-10-29
Product CodeNQD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K042485. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K042485.

When did TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) receive FDA 510(k) clearance?

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042485.

Who is the listed applicant for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

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

What is the FDA product code for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

The FDA product code for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) is NQD.

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Related Devices (Code: NQD)

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.

K260026Tina-quant Cardiac high sensitivity CRP IIIRoche DiagnosticsK233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbHK173833CRP VarioSENTINEL CH. SpAK081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORSSiemens Healthcare Diagnostics, Inc.K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENTBeckman Coulter, Inc.

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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