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FDA 510(k)

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

K-Number: K981698 · 1998-07-10

ApplicantChiron Corp.
Decision Date1998-07-10
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Corp.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K981698. 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 FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)?

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Chiron Corp.. The 510(k) number is K981698.

When did ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) receive FDA 510(k) clearance?

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981698.

Who is the listed applicant for ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)?

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 FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)?

The FDA product code for ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) is MOI.

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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.

K980190ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

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

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