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)

ANTI-SKIN ANTIBODY TEST SYSTEM

K-Number: K811261 · 1981-08-12

ApplicantZeus Scientific, Inc.
Decision Date1981-08-12
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SKIN ANTIBODY TEST SYSTEM 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 1981-08-12 under 510(k) number K811261. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SKIN ANTIBODY TEST SYSTEM?

ANTI-SKIN ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K811261.

When did ANTI-SKIN ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

ANTI-SKIN ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1981-08-12, under 510(k) number K811261.

Who is the listed applicant for ANTI-SKIN ANTIBODY TEST SYSTEM?

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 ANTI-SKIN ANTIBODY TEST SYSTEM?

The FDA product code for ANTI-SKIN ANTIBODY TEST SYSTEM is DBL.

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: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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.

↑