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FDA 510(k)

STRATUS CORTISOL FLUOROMETRIC ENZYME

K-Number: K843183 · 1984-09-17

ApplicantAmerican Dade
Decision Date1984-09-17
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CORTISOL FLUOROMETRIC ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-09-17 under 510(k) number K843183. 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 STRATUS CORTISOL FLUOROMETRIC ENZYME?

STRATUS CORTISOL FLUOROMETRIC ENZYME is a medical device that received FDA 510(k) clearance on 1984-09-17. The listed applicant is American Dade. The 510(k) number is K843183.

When did STRATUS CORTISOL FLUOROMETRIC ENZYME receive FDA 510(k) clearance?

STRATUS CORTISOL FLUOROMETRIC ENZYME received FDA 510(k) clearance on 1984-09-17, under 510(k) number K843183.

Who is the listed applicant for STRATUS CORTISOL FLUOROMETRIC ENZYME?

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

What is the FDA product code for STRATUS CORTISOL FLUOROMETRIC ENZYME?

The FDA product code for STRATUS CORTISOL FLUOROMETRIC ENZYME is CGR.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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

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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