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FDA 510(k)

CORTISOL ENHANCED LUMINESCENCE ASSAY KIT

K-Number: K880687 · 1988-03-24

ApplicantAmersham Corp.
Decision Date1988-03-24
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL ENHANCED LUMINESCENCE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880687. 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 ENHANCED LUMINESCENCE ASSAY KIT?

CORTISOL ENHANCED LUMINESCENCE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Amersham Corp.. The 510(k) number is K880687.

When did CORTISOL ENHANCED LUMINESCENCE ASSAY KIT receive FDA 510(k) clearance?

CORTISOL ENHANCED LUMINESCENCE ASSAY KIT received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880687.

Who is the listed applicant for CORTISOL ENHANCED LUMINESCENCE ASSAY KIT?

The FDA 510(k) record lists Amersham Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTISOL ENHANCED LUMINESCENCE ASSAY KIT?

The FDA product code for CORTISOL ENHANCED LUMINESCENCE ASSAY KIT is CGR.

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Other records listing Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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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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