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FDA 510(k)

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

K-Number: K112545 · 2012-07-31

ApplicantInova Diagnostics, Inc.
Decision Date2012-07-31
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K112545. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM?

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K112545.

When did QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM receive FDA 510(k) clearance?

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM received FDA 510(k) clearance on 2012-07-31, under 510(k) number K112545.

Who is the listed applicant for QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM?

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

What is the FDA product code for QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM?

The FDA product code for QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM is MOB.

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Related Devices (Code: MOB)

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.

K261466Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMZeus ScientificK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova 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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