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FDA 510(k)

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA

K-Number: K990796 · 1999-04-28

ApplicantCogent Diagnotics , Ltd.
Decision Date1999-04-28
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1999-04-28 under 510(k) number K990796. 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 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA?

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA is a medical device that received FDA 510(k) clearance on 1999-04-28. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K990796.

When did AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA receive FDA 510(k) clearance?

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA received FDA 510(k) clearance on 1999-04-28, under 510(k) number K990796.

Who is the listed applicant for AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA?

The FDA 510(k) record lists Cogent Diagnotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA?

The FDA product code for AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA is MOB.

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Other records listing Cogent Diagnotics , Ltd. 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.

K003057AUTOSTAT II ENA-4 PROFILE ELISAK003054AUTOSTAT II ENA-6 PROFILE ELISAK002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISAK993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

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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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