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)

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT

K-Number: K854944 · 1986-08-27

ApplicantAbbott Laboratories
Decision Date1986-08-27
Product CodeDAH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1986-08-27 under 510(k) number K854944. The device is classified under product code DAH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT?

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1986-08-27. The listed applicant is Abbott Laboratories. The 510(k) number is K854944.

When did TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT receive FDA 510(k) clearance?

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT received FDA 510(k) clearance on 1986-08-27, under 510(k) number K854944.

Who is the listed applicant for TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT?

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

What is the FDA product code for TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT?

The FDA product code for TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT is DAH.

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 Abbott Laboratories 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.

K262156Anti-HCV NextK252424Anti-HCV NextK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgGK243283Alinity h-series SystemK233932Alinity i Toxo IgM

View all 876 devices →

Related Devices (Code: DAH)

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.

K931247TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067Helena LaboratoriesK905149TITAN GELHelena LaboratoriesK901805REP(R) IMMUNOFIXHelena LaboratoriesK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GOrion Diagnostica, Inc.K883494TECHNICON DPA-1 IMMUNOGLOBULIN GTechnicon Instruments Corp.K862184DAKO ITA, IMMUNOGLOBULIN M (IGM)Dako Corp.

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.

↑