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FDA 510(k)

NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240

K-Number: K994140 · 2000-05-09

ApplicantNichols Institute Diagnostics
Decision Date2000-05-09
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K994140. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240?

NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K994140.

When did NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 receive FDA 510(k) clearance?

NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 received FDA 510(k) clearance on 2000-05-09, under 510(k) number K994140.

Who is the listed applicant for NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240?

The FDA 510(k) record lists Nichols Institute Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240?

The FDA product code for NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 is MSW.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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Related Devices (Code: MSW)

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.

K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K240927Access ThyroglobulinBeckman Coulter, Inc.K241423Access ThyroglobulinBeckman Coulter, Inc.K221890Elecsys Tg IIRoche DiagnosticsK220972Access ThyroglobulinBeckman Coulter, Inc.K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.

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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