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FDA 510(k)

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

K-Number: K991890 · 1999-08-09

ApplicantCogent Diagnotics , Ltd.
Decision Date1999-08-09
Product CodeMVJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB 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 1999-08-09 under 510(k) number K991890. The device is classified under product code MVJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA?

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA is a medical device that received FDA 510(k) clearance on 1999-08-09. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K991890.

When did AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA receive FDA 510(k) clearance?

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA received FDA 510(k) clearance on 1999-08-09, under 510(k) number K991890.

Who is the listed applicant for AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB 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-GBM ELISA, HY.TEC ANTI-GMB ELISA?

The FDA product code for AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA is MVJ.

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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.

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Related Devices (Code: MVJ)

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.

K071219ATHENA MULTI-LYTE GBM TEST SYSTEMZeus Scientific, Inc.K072358BIOPLEX VASCULITIS KITBio-Rad LaboratoriesK011348PHASE II GBM IGG ANTIBODY EIA TESTScimedx Corp.K984619BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.K984336QUANTA LITE GBM 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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