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FDA 510(k)

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)

K-Number: K032860 · 2004-03-18

ApplicantImmco Diagnostics, Inc.
Decision Date2004-03-18
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-03-18 under 510(k) number K032860. The device is classified under product code NBT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)?

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) is a medical device that received FDA 510(k) clearance on 2004-03-18. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K032860.

When did IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) receive FDA 510(k) clearance?

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) received FDA 510(k) clearance on 2004-03-18, under 510(k) number K032860.

Who is the listed applicant for IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)?

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

What is the FDA product code for IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)?

The FDA product code for IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) is NBT.

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Other records listing Immco Diagnostics, 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.

K172745ImmuGlo HEp-2 Elite IFAK172078ImmuLisa Enhanced RNA POL III Antibody ELISAK163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAK163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAK151559ImmuLisa Enhanced Centromere Antibody ELISA

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Related Devices (Code: NBT)

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.

K071711ASCA-CHEKTechlab Inc., Corporate Research CenterK051927TECHLAB ASCA-CHEKTechlab, Inc.K051492AESKULISA ASCA AAesku, Inc.K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding SiteK032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)Immco Diagnostics, Inc.K000733QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISAInova Diagnostics, 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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