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FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

K-Number: K983990 · 1998-12-29

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date1998-12-29
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL 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 1998-12-29 under 510(k) number K983990. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY?

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY is a medical device that received FDA 510(k) clearance on 1998-12-29. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K983990.

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

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY received FDA 510(k) clearance on 1998-12-29, under 510(k) number K983990.

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

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY is CGR.

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Official Source

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