FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

K-Number: K031031 · 2003-09-29

ApplicantOrtho-Clinical Diagnostics, Inc.

Decision Date2003-09-29

Product CodeMMI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-09-29 under 510(k) number K031031. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS?

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K031031.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS received FDA 510(k) clearance on 2003-09-29, under 510(k) number K031031.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS is MMI.

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Other records listing Ortho-Clinical Diagnostics, Inc. as applicant

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent Pack K210858VITROS Chemistry Products PHBR Slides K191316VITROS XT Chemistry Products ALB-TP Slides K190807VITROS XT Chemistry Products TBIL-ALKP Slides K190520VITROS XT Chemistry Products GLU-Ca Slides K190490VITROS XT Chemistry Products TRIG-CHOL Slides

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Related Devices (Code: MMI)

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, 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.