FDA 510(k)

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)

K-Number: K072440 · 2007-09-20

ApplicantOrtho-Clinical Diagnostics, Inc.

Decision Date2007-09-20

Product CodeCJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) 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 2007-09-20 under 510(k) number K072440. 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 SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)?

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K072440.

When did VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) received FDA 510(k) clearance on 2007-09-20, under 510(k) number K072440.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)?

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 SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)?

The FDA product code for VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) is CJY.

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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.