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(TM) ANTI-DSNA

K-Number: K913342 · 1992-05-01

ApplicantCogent Diagnotics , Ltd.
Decision Date1992-05-01
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT(TM) ANTI-DSNA 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 1992-05-01 under 510(k) number K913342. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSTAT(TM) ANTI-DSNA?

AUTOSTAT(TM) ANTI-DSNA is a medical device that received FDA 510(k) clearance on 1992-05-01. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K913342.

When did AUTOSTAT(TM) ANTI-DSNA receive FDA 510(k) clearance?

AUTOSTAT(TM) ANTI-DSNA received FDA 510(k) clearance on 1992-05-01, under 510(k) number K913342.

Who is the listed applicant for AUTOSTAT(TM) ANTI-DSNA?

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(TM) ANTI-DSNA?

The FDA product code for AUTOSTAT(TM) ANTI-DSNA is LKJ.

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: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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.

↑