FDA 510(k)

EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)

K-Number: K961196 · 1996-05-15

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.

Decision Date1996-05-15

Product CodeCDN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-05-15 under 510(k) number K961196. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)?

EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K961196.

When did EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) receive FDA 510(k) clearance?

EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) received FDA 510(k) clearance on 1996-05-15, under 510(k) number K961196.

Who is the listed applicant for EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)?

The FDA 510(k) record lists Johnson & Johnson Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)?

The FDA product code for EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) is CDN.

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Related Devices (Code: CDN)

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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.