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FDA 510(k)

SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)

K-Number: K914886 · 1992-03-02

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1992-03-02
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K914886. 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 SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)?

SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K914886.

When did SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) receive FDA 510(k) clearance?

SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) received FDA 510(k) clearance on 1992-03-02, under 510(k) number K914886.

Who is the listed applicant for SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)?

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

What is the FDA product code for SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)?

The FDA product code for SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) is CGR.

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Other records listing Serono-Baker Diagnostics, Inc. as applicant

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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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