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FDA 510(k)

AUTOANTIBODY SCREEN TEST SYSTEM

K-Number: K831358 · 1983-06-15

ApplicantZeus Scientific, Inc.
Decision Date1983-06-15
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOANTIBODY SCREEN 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 1983-06-15 under 510(k) number K831358. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOANTIBODY SCREEN TEST SYSTEM?

AUTOANTIBODY SCREEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-15. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K831358.

When did AUTOANTIBODY SCREEN TEST SYSTEM receive FDA 510(k) clearance?

AUTOANTIBODY SCREEN TEST SYSTEM received FDA 510(k) clearance on 1983-06-15, under 510(k) number K831358.

Who is the listed applicant for AUTOANTIBODY SCREEN 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 AUTOANTIBODY SCREEN TEST SYSTEM?

The FDA product code for AUTOANTIBODY SCREEN TEST SYSTEM is DBM.

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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

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Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, 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.

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