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FDA 510(k)

VIDAS TOTAL IGE (IGE) ASSAY

K-Number: K931224 · 1993-05-20

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-05-20
Product CodeDGP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIDAS TOTAL IGE (IGE) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K931224. The device is classified under product code DGP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS TOTAL IGE (IGE) ASSAY?

VIDAS TOTAL IGE (IGE) ASSAY is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K931224.

When did VIDAS TOTAL IGE (IGE) ASSAY receive FDA 510(k) clearance?

VIDAS TOTAL IGE (IGE) ASSAY received FDA 510(k) clearance on 1993-05-20, under 510(k) number K931224.

Who is the listed applicant for VIDAS TOTAL IGE (IGE) ASSAY?

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

What is the FDA product code for VIDAS TOTAL IGE (IGE) ASSAY?

The FDA product code for VIDAS TOTAL IGE (IGE) ASSAY is DGP.

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Other records listing Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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Related Devices (Code: DGP)

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.

K863327IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.K842749FIAX TOTAL IGE TEST KITIntl. Diagnostic TechnologyK842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMAllergenetics

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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