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)

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III

K-Number: K982649 · 1998-08-12

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date1998-08-12
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-08-12 under 510(k) number K982649. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III?

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III is a medical device that received FDA 510(k) clearance on 1998-08-12. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K982649.

When did VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III received FDA 510(k) clearance on 1998-08-12, under 510(k) number K982649.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III?

The FDA product code for VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III is DIF.

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 Ortho-Clinical Diagnostics, Inc. 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.

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackK210858VITROS Chemistry Products PHBR SlidesK191316VITROS XT Chemistry Products ALB-TP SlidesK190807VITROS XT Chemistry Products TBIL-ALKP SlidesK190520VITROS XT Chemistry Products GLU-Ca SlidesK190490VITROS XT Chemistry Products TRIG-CHOL Slides

View all 104 devices →

Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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.

↑