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)

ACL AcuStar

K-Number: K170314 · 2017-03-03

ApplicantInstrumentation Laboratory CO
Decision Date2017-03-03
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL AcuStar is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2017-03-03 under approval number K170314. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACL AcuStar?

ACL AcuStar is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K170314.

When was ACL AcuStar approved by the FDA?

ACL AcuStar received FDA 510(k) clearance on 2017-03-03, under approval number K170314.

What company makes ACL AcuStar?

ACL AcuStar is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for ACL AcuStar?

The FDA product code for ACL AcuStar is JPA.

Other Devices by Instrumentation Laboratory CO

K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160885HemosIL D-Dimer HS K161818GEM Premier 3000

View all 26 devices →

Related Devices (Code: JPA)

K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH

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.

↑