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FDA 510(k)

CORALENT COAT 125I CORTISOL RADIOIMM.

K-Number: K791835 · 1979-09-27

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1979-09-27
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORALENT COAT 125I CORTISOL RADIOIMM. is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791835. 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 CORALENT COAT 125I CORTISOL RADIOIMM.?

CORALENT COAT 125I CORTISOL RADIOIMM. is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K791835.

When did CORALENT COAT 125I CORTISOL RADIOIMM. receive FDA 510(k) clearance?

CORALENT COAT 125I CORTISOL RADIOIMM. received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791835.

Who is the listed applicant for CORALENT COAT 125I CORTISOL RADIOIMM.?

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

What is the FDA product code for CORALENT COAT 125I CORTISOL RADIOIMM.?

The FDA product code for CORALENT COAT 125I CORTISOL RADIOIMM. is CGR.

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Other records listing Radioassay Systems Laboratories, 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.

K862204RSL (125I) ALDOSTERONE KITK842960ANDROSTENEDIONE BY RIAK840886HYDROXYPROGESTERONE BY RIA 17AK831855HATCH KITK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KIT

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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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