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FDA 510(k)

MODIFICATION TO DIADEXUS PLAC TEST

K-Number: K040101 · 2004-02-05

ApplicantDiadexus, Inc.
Decision Date2004-02-05
Product CodeNOE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DIADEXUS PLAC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diadexus, Inc.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K040101. The device is classified under product code NOE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO DIADEXUS PLAC TEST?

MODIFICATION TO DIADEXUS PLAC TEST is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is Diadexus, Inc.. The 510(k) number is K040101.

When did MODIFICATION TO DIADEXUS PLAC TEST receive FDA 510(k) clearance?

MODIFICATION TO DIADEXUS PLAC TEST received FDA 510(k) clearance on 2004-02-05, under 510(k) number K040101.

Who is the listed applicant for MODIFICATION TO DIADEXUS PLAC TEST?

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

What is the FDA product code for MODIFICATION TO DIADEXUS PLAC TEST?

The FDA product code for MODIFICATION TO DIADEXUS PLAC TEST is NOE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Diadexus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101853PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115K072599PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109K062234MODIFICATION TO DIADEXUS PLAC TESTK050523DIADEXUS PLAC TESTK030477DIADEXUS PLAC TEST

Related Devices (Code: NOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203136Diazyme PLAC® Test for Lp-PLA2 ActivityDiazyme Laboratories, Inc.K101853PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115Diadexus, Inc.K072599PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109Diadexus, Inc.K062234MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.K050523DIADEXUS PLAC TESTDiadexus, Inc.K030477DIADEXUS PLAC TESTDiadexus, Inc.

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.

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