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FDA 510(k)

ZETA-CORT

K-Number: K821931 · 1982-07-22

ApplicantAmf Biological and Diagnostics Co.
Decision Date1982-07-22
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ZETA-CORT is the device name listed in this FDA 510(k) record. The listed applicant is Amf Biological and Diagnostics Co.. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821931. 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 ZETA-CORT?

ZETA-CORT is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Amf Biological and Diagnostics Co.. The 510(k) number is K821931.

When did ZETA-CORT receive FDA 510(k) clearance?

ZETA-CORT received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821931.

Who is the listed applicant for ZETA-CORT?

The FDA 510(k) record lists Amf Biological and Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZETA-CORT?

The FDA product code for ZETA-CORT is CGR.

Other records listing Amf Biological and Diagnostics Co. 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.

K852418QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)K821553ZETAPHASE T3 UPTAKE DIAGNOSTIC KITK821554ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KITK812329ZETA-SERA D

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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