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FDA 510(k)

CHIRON DIAGNOSTICS ACS: 180 FOLATE

K-Number: K991582 · 1999-06-30

ApplicantChiron Diagnostics Corp.
Decision Date1999-06-30
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHIRON DIAGNOSTICS ACS: 180 FOLATE 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 1999-06-30 under 510(k) number K991582. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIRON DIAGNOSTICS ACS: 180 FOLATE?

CHIRON DIAGNOSTICS ACS: 180 FOLATE is a medical device that received FDA 510(k) clearance on 1999-06-30. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K991582.

When did CHIRON DIAGNOSTICS ACS: 180 FOLATE receive FDA 510(k) clearance?

CHIRON DIAGNOSTICS ACS: 180 FOLATE received FDA 510(k) clearance on 1999-06-30, under 510(k) number K991582.

Who is the listed applicant for CHIRON DIAGNOSTICS ACS: 180 FOLATE?

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 CHIRON DIAGNOSTICS ACS: 180 FOLATE?

The FDA product code for CHIRON DIAGNOSTICS ACS: 180 FOLATE is CGN.

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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 ASSAYK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981478ACS:CENTAUR CEAK981839ACS:CENTAUR PSA2 IMMUNOASSAYK981592ACS:CENTAUR AFP

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Related Devices (Code: CGN)

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.

K233060Elecsys Folate IIIRoche DiagnosticsK223590Access Folate AssayBeckman Coulter, Inc.K192586LIAISON® FolateDiaSorin, Inc.K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme LaboratoriesK103716ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSETRoche 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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