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)

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

K-Number: K983422 · 1998-11-18

ApplicantZeus Scientific, Inc.
Decision Date1998-11-18
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983422. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET?

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K983422.

When did THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET receive FDA 510(k) clearance?

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983422.

Who is the listed applicant for THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET?

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

What is the FDA product code for THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET?

The FDA product code for THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET is LRM.

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 Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

View all 135 devices →

Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, 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.

↑