FDA 510(k)

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

K-Number: K954933 · 1995-12-18

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.

Decision Date1995-12-18

Product CodeLDP

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN 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 1995-12-18 under 510(k) number K954933. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN?

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K954933.

When did EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN receive FDA 510(k) clearance?

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954933.

Who is the listed applicant for EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN?

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 FOR ACETAMINOPHEN?

The FDA product code for EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN is LDP.

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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.