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FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

K-Number: K012561 · 2001-08-29

ApplicantOrtho-Clinical Diagnostics
Decision Date2001-08-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics. It received FDA 510(k) clearance on 2001-08-29 under 510(k) number K012561. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS?

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS is a medical device that received FDA 510(k) clearance on 2001-08-29. The listed applicant is Ortho-Clinical Diagnostics. The 510(k) number is K012561.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS received FDA 510(k) clearance on 2001-08-29, under 510(k) number K012561.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS?

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

What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS is JJX.

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Related Devices (Code: JJX)

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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.

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