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

FDA 510(k)

ABX PENTRA TPU CAL, MODEL A11A01898

K-Number: K092570 · 2009-10-16

ApplicantHORIBA ABX SAS
Decision Date2009-10-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABX PENTRA TPU CAL, MODEL A11A01898 is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K092570. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA TPU CAL, MODEL A11A01898?

ABX PENTRA TPU CAL, MODEL A11A01898 is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is HORIBA ABX SAS. The 510(k) number is K092570.

When did ABX PENTRA TPU CAL, MODEL A11A01898 receive FDA 510(k) clearance?

ABX PENTRA TPU CAL, MODEL A11A01898 received FDA 510(k) clearance on 2009-10-16, under 510(k) number K092570.

Who is the listed applicant for ABX PENTRA TPU CAL, MODEL A11A01898?

The FDA 510(k) record lists HORIBA ABX SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABX PENTRA TPU CAL, MODEL A11A01898?

The FDA product code for ABX PENTRA TPU CAL, MODEL A11A01898 is JIT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing HORIBA ABX SAS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260781Yumizen H550K232946Yumizen H2500K193649Yumizen C1200 Creatinine PAPK193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MK192028Yumizen C1200 CRPK191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

View all 15 devices →

Related Devices (Code: JIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio 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.

↑