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FDA 510(k)

CORTISOL RADIOIMMUNOASSAY KIT

K-Number: K832638 · 1983-09-12

ApplicantBioclinical Group
Decision Date1983-09-12
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Group. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832638. 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 RADIOIMMUNOASSAY KIT?

CORTISOL RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Bioclinical Group. The 510(k) number is K832638.

When did CORTISOL RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

CORTISOL RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832638.

Who is the listed applicant for CORTISOL RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for CORTISOL RADIOIMMUNOASSAY KIT?

The FDA product code for CORTISOL RADIOIMMUNOASSAY KIT is CGR.

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Other records listing Bioclinical Group 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.

K862968FREE T3 RADIOIMMUNOASSAY KITK853837LH/FSH RADIOIMMUNOASSAY KITK823005BIO MAG FREE T4 RADIOIMMUNOASSAY KITK823004BIO MAG TOTAL T4 RADIOIMMUNOASSAY KITK822840RADIOIMMUNOASSAY, HUMAN CHORRIONICK822515B-HCG RADIOIMMUNOASSAY KIT

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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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