FDA 510(k)

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

K-Number: K072443 · 2007-09-24

ApplicantOrtho-Clinical Diagnostics, Inc.

Decision Date2007-09-24

Product CodeCJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA 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 2007-09-24 under 510(k) number K072443. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY?

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY is a medical device that received FDA 510(k) clearance on 2007-09-24. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K072443.

When did VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY received FDA 510(k) clearance on 2007-09-24, under 510(k) number K072443.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA 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 CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY?

The FDA product code for VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY is CJY.

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Related Devices (Code: CJY)

K244042Calcium2Abbott Ireland K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SAS K182042Randox Calcium (Ca)Randox Laboratories, Ltd.K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SAS K120626EON CALCIUM REGENTVital Diagnostics (Manufacturing) Ptyltd K083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics

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.