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FDA 510(k)

CORTISOL125 RADIOIMMUNOASSAY

K-Number: K802036 · 1980-10-23

ApplicantCorning Medical & Scientific
Decision Date1980-10-23
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL125 RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802036. 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 CORTISOL125 RADIOIMMUNOASSAY?

CORTISOL125 RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Corning Medical & Scientific. The 510(k) number is K802036.

When did CORTISOL125 RADIOIMMUNOASSAY receive FDA 510(k) clearance?

CORTISOL125 RADIOIMMUNOASSAY received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802036.

Who is the listed applicant for CORTISOL125 RADIOIMMUNOASSAY?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL125 RADIOIMMUNOASSAY?

The FDA product code for CORTISOL125 RADIOIMMUNOASSAY is CGR.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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Related Devices (Code: CGR)

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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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