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FDA 510(k)

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

K-Number: K870969 · 1987-06-22

ApplicantCanadian Bioclinical, Ltd.
Decision Date1987-06-22
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Bioclinical, Ltd.. It received FDA 510(k) clearance on 1987-06-22 under 510(k) number K870969. 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-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-06-22. The listed applicant is Canadian Bioclinical, Ltd.. The 510(k) number is K870969.

When did CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1987-06-22, under 510(k) number K870969.

Who is the listed applicant for CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA product code for CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is CGR.

Related Clinical Trials

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.

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Other records listing Canadian Bioclinical, Ltd. 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.

K933794ANI BIOCARD(TM) HCG TESTK870968TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KITK864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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