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FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY

K-Number: K983031 · 1998-12-18

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date1998-12-18
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY 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 1998-12-18 under 510(k) number K983031. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY?

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY is a medical device that received FDA 510(k) clearance on 1998-12-18. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K983031.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY received FDA 510(k) clearance on 1998-12-18, under 510(k) number K983031.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY?

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 AFP ASSAY?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY is LOJ.

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Other records listing Ortho-Clinical Diagnostics, 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.

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackK210858VITROS Chemistry Products PHBR SlidesK191316VITROS XT Chemistry Products ALB-TP SlidesK190807VITROS XT Chemistry Products TBIL-ALKP SlidesK190520VITROS XT Chemistry Products GLU-Ca SlidesK190490VITROS XT Chemistry Products TRIG-CHOL Slides

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Related Devices (Code: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade Behring, 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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