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)

AG CHEMISTRY ANALYZER SYSTEM

K-Number: K972409 · 1997-08-28

ApplicantLandmark Scientific, Inc.
Decision Date1997-08-28
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AG CHEMISTRY ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Landmark Scientific, Inc.. It received FDA 510(k) clearance on 1997-08-28 under 510(k) number K972409. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AG CHEMISTRY ANALYZER SYSTEM?

AG CHEMISTRY ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Landmark Scientific, Inc.. The 510(k) number is K972409.

When did AG CHEMISTRY ANALYZER SYSTEM receive FDA 510(k) clearance?

AG CHEMISTRY ANALYZER SYSTEM received FDA 510(k) clearance on 1997-08-28, under 510(k) number K972409.

Who is the listed applicant for AG CHEMISTRY ANALYZER SYSTEM?

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

What is the FDA product code for AG CHEMISTRY ANALYZER SYSTEM?

The FDA product code for AG CHEMISTRY ANALYZER SYSTEM is JJG.

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

Related Devices (Code: JJG)

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.

K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.K893854COBAS FARA II CENTRIFUGAL ANALYZERRoche Diagnostic Systems, 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.

↑