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FDA 510(k)

CORTISOL RADIOIMMUNOASSAY SYSTEM

K-Number: K792036 · 1979-10-30

ApplicantRadioimmunoassay, Inc.
Decision Date1979-10-30
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL RADIOIMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radioimmunoassay, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792036. 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 SYSTEM?

CORTISOL RADIOIMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Radioimmunoassay, Inc.. The 510(k) number is K792036.

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

CORTISOL RADIOIMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792036.

Who is the listed applicant for CORTISOL RADIOIMMUNOASSAY SYSTEM?

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

What is the FDA product code for CORTISOL RADIOIMMUNOASSAY SYSTEM?

The FDA product code for CORTISOL RADIOIMMUNOASSAY SYSTEM is CGR.

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Other records listing Radioimmunoassay, Inc. 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.

K802135TESTOSTERONE RADIOIMMUNOASSY KITK800106LUTEINIZING HORMONE RADIOIMMUNOASSAY SYSK800107FOLLICLE STIMULATING HORMONEK792539TRIIODOTHYRONINE RIA SYSTEMK792153DIGOXIN RADIOIMMUNOASSAY SYSTEMK792154THYROID STIMULATING HORMONE

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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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