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FDA 510(k)

CORTISOL CHEMILUMINESCENCE ASSAY

K-Number: K922676 · 1992-07-10

ApplicantNichols Institute
Decision Date1992-07-10
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL CHEMILUMINESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1992-07-10 under 510(k) number K922676. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTISOL CHEMILUMINESCENCE ASSAY?

CORTISOL CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Nichols Institute. The 510(k) number is K922676.

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

CORTISOL CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1992-07-10, under 510(k) number K922676.

Who is the listed applicant for CORTISOL CHEMILUMINESCENCE ASSAY?

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

What is the FDA product code for CORTISOL CHEMILUMINESCENCE ASSAY?

The FDA product code for CORTISOL CHEMILUMINESCENCE ASSAY is CGR.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

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Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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