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FDA 510(k)

FOLATE RADIOASSAY KIT CA-1562-125

K-Number: K832712 · 1983-10-04

ApplicantClinical Assays, Inc.
Decision Date1983-10-04
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOLATE RADIOASSAY KIT CA-1562-125 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832712. 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 FOLATE RADIOASSAY KIT CA-1562-125?

FOLATE RADIOASSAY KIT CA-1562-125 is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K832712.

When did FOLATE RADIOASSAY KIT CA-1562-125 receive FDA 510(k) clearance?

FOLATE RADIOASSAY KIT CA-1562-125 received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832712.

Who is the listed applicant for FOLATE RADIOASSAY KIT CA-1562-125?

The FDA 510(k) record lists Clinical Assays, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOLATE RADIOASSAY KIT CA-1562-125?

The FDA product code for FOLATE RADIOASSAY KIT CA-1562-125 is CGN.

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Other records listing Clinical Assays, Inc. 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.

K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832711VITAMIN B12 FOLATE CA-1515-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KITK821092GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

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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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