Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

K-Number: K991942 · 1999-08-24

ApplicantCogent Diagnotics , Ltd.
Decision Date1999-08-24
Product CodeMLE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC 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 1999-08-24 under 510(k) number K991942. The device is classified under product code MLE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA is a medical device that received FDA 510(k) clearance on 1999-08-24. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K991942.

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

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA received FDA 510(k) clearance on 1999-08-24, under 510(k) number K991942.

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

The FDA product code for AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA is MLE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 31 devices →

Related Devices (Code: MLE)

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.

K010558QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISAInova Diagnostics, Inc.K951206VARELISA PARIETAL CELL ANTIBODIESElias U.S.A., 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.

↑