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)

ORTHO CLASSICAL PATHWAY COMPL. TEST

K-Number: K821898 · 1982-07-16

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1982-07-16
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORTHO CLASSICAL PATHWAY COMPL. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1982-07-16 under 510(k) number K821898. The device is classified under product code DBA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO CLASSICAL PATHWAY COMPL. TEST?

ORTHO CLASSICAL PATHWAY COMPL. TEST is a medical device that received FDA 510(k) clearance on 1982-07-16. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K821898.

When did ORTHO CLASSICAL PATHWAY COMPL. TEST receive FDA 510(k) clearance?

ORTHO CLASSICAL PATHWAY COMPL. TEST received FDA 510(k) clearance on 1982-07-16, under 510(k) number K821898.

Who is the listed applicant for ORTHO CLASSICAL PATHWAY COMPL. TEST?

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

What is the FDA product code for ORTHO CLASSICAL PATHWAY COMPL. TEST?

The FDA product code for ORTHO CLASSICAL PATHWAY COMPL. TEST is DBA.

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 Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: DBA)

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.

K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.K072965DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDade Behring, Inc.K011780K-ASSAY C1-INAKamiya Biomedical Co.K003747C1-INHIBITOR MICROTITER ASSAY DEVICEBaxter Healthcare CorpK965024N-ASSAY TIA C1-INACTIVATOR TEST KITCrestat Diagnostics, Inc.K960257N ANTISERUM TO C1 INHIBITORBehring 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.

↑