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)

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

K-Number: K980190 · 1998-03-06

ApplicantChiron Corp.
Decision Date1998-03-06
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Corp.. It received FDA 510(k) clearance on 1998-03-06 under 510(k) number K980190. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)?

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) is a medical device that received FDA 510(k) clearance on 1998-03-06. The listed applicant is Chiron Corp.. The 510(k) number is K980190.

When did ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) receive FDA 510(k) clearance?

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) received FDA 510(k) clearance on 1998-03-06, under 510(k) number K980190.

Who is the listed applicant for ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)?

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

What is the FDA product code for ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)?

The FDA product code for ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) is MOI.

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 Chiron Corp. 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.

K981698ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)

Related Devices (Code: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche Diagnostics

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.

↑