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 Free PS Ag

K-Number: K181525 · 2018-09-07

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2018-09-07
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE Free PS Ag is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-09-07 under approval number K181525. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE Free PS Ag?

INNOVANCE Free PS Ag is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K181525.

When was INNOVANCE Free PS Ag approved by the FDA?

INNOVANCE Free PS Ag received FDA 510(k) clearance on 2018-09-07, under approval number K181525.

What company makes INNOVANCE Free PS Ag?

INNOVANCE Free PS Ag is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for INNOVANCE Free PS Ag?

The FDA product code for INNOVANCE Free PS Ag is GGP.

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: GGP)

K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc. K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company

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.

↑