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FDA 510(k)

IN VITRO FOLATE RADIOASSAY KIT

K-Number: K771597 · 1977-09-13

ApplicantClinical Assays, Inc.
Decision Date1977-09-13
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO FOLATE RADIOASSAY KIT 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 1977-09-13 under 510(k) number K771597. 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 IN VITRO FOLATE RADIOASSAY KIT?

IN VITRO FOLATE RADIOASSAY KIT is a medical device that received FDA 510(k) clearance on 1977-09-13. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K771597.

When did IN VITRO FOLATE RADIOASSAY KIT receive FDA 510(k) clearance?

IN VITRO FOLATE RADIOASSAY KIT received FDA 510(k) clearance on 1977-09-13, under 510(k) number K771597.

Who is the listed applicant for IN VITRO FOLATE RADIOASSAY KIT?

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 IN VITRO FOLATE RADIOASSAY KIT?

The FDA product code for IN VITRO FOLATE RADIOASSAY KIT is CGN.

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Other records listing Clinical Assays, Inc. as applicant

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K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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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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