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)

IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.

K-Number: K871973 · 1987-06-11

ApplicantInstrumentation Laboratory CO
Decision Date1987-06-11
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871973. 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 IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.?

IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K871973.

When did IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. receive FDA 510(k) clearance?

IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871973.

Who is the listed applicant for IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.?

The FDA product code for IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. 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

Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

View all 315 devices →

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.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.

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.

↑