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FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

K-Number: K990061 · 1999-01-25

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date1999-01-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS 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 1999-01-25 under 510(k) number K990061. 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 AFP RANGE VERIFIERS?

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS is a medical device that received FDA 510(k) clearance on 1999-01-25. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K990061.

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

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS received FDA 510(k) clearance on 1999-01-25, under 510(k) number K990061.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS?

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 RANGE VERIFIERS?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS is JJX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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