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FDA 510(k)

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

K-Number: K970695 · 1997-08-08

ApplicantChiron Diagnostics Corp.
Decision Date1997-08-08
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 Diagnostics Corp.. It received FDA 510(k) clearance on 1997-08-08 under 510(k) number K970695. 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 1997-08-08. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K970695.

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 1997-08-08, under 510(k) number K970695.

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 Diagnostics 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 Diagnostics 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.

K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYK991582CHIRON DIAGNOSTICS ACS: 180 FOLATEK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981478ACS:CENTAUR CEAK981839ACS:CENTAUR PSA2 IMMUNOASSAY

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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.

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