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FDA 510(k)

PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109

K-Number: K072599 · 2007-12-20

ApplicantDiadexus, Inc.
Decision Date2007-12-20
Product CodeNOE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 is the device name listed in this FDA 510(k) record. The listed applicant is Diadexus, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K072599. 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 PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109?

PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Diadexus, Inc.. The 510(k) number is K072599.

When did PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 receive FDA 510(k) clearance?

PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 received FDA 510(k) clearance on 2007-12-20, under 510(k) number K072599.

Who is the listed applicant for PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109?

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 PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109?

The FDA product code for PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, 10-0115K062234MODIFICATION TO DIADEXUS PLAC TESTK050523DIADEXUS PLAC TESTK040101MODIFICATION TO DIADEXUS 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.K062234MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.K050523DIADEXUS PLAC TESTDiadexus, Inc.K040101MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.K030477DIADEXUS PLAC TESTDiadexus, Inc.

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.

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