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FDA 510(k)

TOTAL T3 CHEMILUMINESCENCE ASSAY

K-Number: K923015 · 1992-09-02

ApplicantNichols Institute Diagnostics
Decision Date1992-09-02
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL T3 CHEMILUMINESCENCE ASSAY 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 1992-09-02 under 510(k) number K923015. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL T3 CHEMILUMINESCENCE ASSAY?

TOTAL T3 CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K923015.

When did TOTAL T3 CHEMILUMINESCENCE ASSAY receive FDA 510(k) clearance?

TOTAL T3 CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1992-09-02, under 510(k) number K923015.

Who is the listed applicant for TOTAL T3 CHEMILUMINESCENCE ASSAY?

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 TOTAL T3 CHEMILUMINESCENCE ASSAY?

The FDA product code for TOTAL T3 CHEMILUMINESCENCE ASSAY is CDP.

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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

View all 68 devices →

Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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