FDA 510(k)

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

K-Number: K100200 · 2010-08-02

Decision Date2010-08-02

Product CodeLDP

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K100200. 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 ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138?

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K100200.

When did ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 receive FDA 510(k) clearance?

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 received FDA 510(k) clearance on 2010-08-02, under 510(k) number K100200.

Who is the listed applicant for ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138?

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

What is the FDA product code for ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138?

The FDA product code for ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 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.