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)

ABNORMAL REFERENCE PLASMA-IX

K-Number: K895504 · 1989-10-06

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-10-06
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABNORMAL REFERENCE PLASMA-IX is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895504. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABNORMAL REFERENCE PLASMA-IX?

ABNORMAL REFERENCE PLASMA-IX is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K895504.

When did ABNORMAL REFERENCE PLASMA-IX receive FDA 510(k) clearance?

ABNORMAL REFERENCE PLASMA-IX received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895504.

Who is the listed applicant for ABNORMAL REFERENCE PLASMA-IX?

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

What is the FDA product code for ABNORMAL REFERENCE PLASMA-IX?

The FDA product code for ABNORMAL REFERENCE PLASMA-IX is GJT.

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 Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

View all 57 devices →

Related Devices (Code: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO

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.

↑