Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

K-Number: K240315 · 2024-10-10

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2024-10-10
Product CodeQLU
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2024-10-10 under approval number K240315. The device is classified under product code QLU. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)?

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K240315.

When was INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) approved by the FDA?

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) received FDA 510(k) clearance on 2024-10-10, under approval number K240315.

What company makes INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)?

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)?

The FDA product code for INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) is QLU.

Related PubMed Literature

PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Siemens Healthcare Diagnostics Products GmbH

K162688Sysmex CS-2100i K162420Sysmex Automated Blood Coagulation Analyzer CS-5100 K161317Sysmex Automated Blood Coagulation Analyzer CS-5100 K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i K151259Sysmex Automated Blood Coagulation Analyzer CS-2100i K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

View all 19 devices →

Related Devices (Code: QLU)

DEN190032HemosIL Liquid Anti-XaInstrumentation Laboratory CO K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO

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.

↑