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 Syphilis

K-Number: K241427 · 2024-09-06

ApplicantBeckman Coulter, Inc.
Decision Date2024-09-06
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access Syphilis is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-09-06 under approval number K241427. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Syphilis?

Access Syphilis is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K241427.

When was Access Syphilis approved by the FDA?

Access Syphilis received FDA 510(k) clearance on 2024-09-06, under approval number K241427.

What company makes Access Syphilis?

Access Syphilis is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Syphilis?

The FDA product code for Access Syphilis is LIP.

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: LIP)

K160910Elecsys SyphilisRoche Diagnostics K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlAbbott Laboratories K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories K211302Elecsys SyphilisRoche Diagnostics K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics

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.

↑