FDA 510(k)

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)

K-Number: K961115 · 1996-05-07

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.

Decision Date1996-05-07

Product CodeCEM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) 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 1996-05-07 under 510(k) number K961115. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)?

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K961115.

When did EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) receive FDA 510(k) clearance?

EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) received FDA 510(k) clearance on 1996-05-07, under 510(k) number K961115.

Who is the listed applicant for EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)?

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 SLIDE POTASSIUM (K+)?

The FDA product code for EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) is CEM.

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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.