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FDA 510(k)

UNICAP GLIADIN IGA ASSAY

K-Number: K982533 · 1998-10-22

ApplicantPharmacia & Upjohn Co.
Decision Date1998-10-22
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UNICAP GLIADIN IGA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia & Upjohn Co.. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K982533. The device is classified under product code MST. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICAP GLIADIN IGA ASSAY?

UNICAP GLIADIN IGA ASSAY is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Pharmacia & Upjohn Co.. The 510(k) number is K982533.

When did UNICAP GLIADIN IGA ASSAY receive FDA 510(k) clearance?

UNICAP GLIADIN IGA ASSAY received FDA 510(k) clearance on 1998-10-22, under 510(k) number K982533.

Who is the listed applicant for UNICAP GLIADIN IGA ASSAY?

The FDA 510(k) record lists Pharmacia & Upjohn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNICAP GLIADIN IGA ASSAY?

The FDA product code for UNICAP GLIADIN IGA ASSAY is MST.

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Other records listing Pharmacia & Upjohn Co. 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.

K003414VARELISA TG (THYROGLOBULIN) ANTIBODIES,K002556CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1K000312VARELISA SM ANTIBODIESK000132ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8K993585VARELISA TPO ANTIBODIES, MODEL 12348/12396K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F

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Related Devices (Code: MST)

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.

K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAImmco Diagnostics, Inc.K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKAesku DiagnosticsK113377GLIADIN IGA AND GLIADIN LGAGrifols USA, LLCK113863QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSInova Diagnostics, Inc.K111414QUANTA FLASH (TM) DGP SCREENInova Diagnostics, Inc.K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01Phadia US, 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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