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)

Access hsTnl

K-Number: K172787 · 2018-06-14

ApplicantBeckman Coulter, Inc.
Decision Date2018-06-14
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access hsTnl is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K172787. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access hsTnl?

Access hsTnl is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K172787.

When was Access hsTnl approved by the FDA?

Access hsTnl received FDA 510(k) clearance on 2018-06-14, under approval number K172787.

What company makes Access hsTnl?

Access hsTnl is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access hsTnl?

The FDA product code for Access hsTnl is MMI.

Other Devices by Beckman Coulter, Inc.

K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

View all 77 devices →

Related Devices (Code: MMI)

K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5Roche Diagnostics K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K172783Access hs TnlBeckman Coulter, Inc. K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, 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.

↑