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FDA 510(k)

CORTISOL KIT

K-Number: K830148 · 1983-02-09

ApplicantCambridge Medical Technology
Decision Date1983-02-09
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Technology. It received FDA 510(k) clearance on 1983-02-09 under 510(k) number K830148. 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 KIT?

CORTISOL KIT is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is Cambridge Medical Technology. The 510(k) number is K830148.

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

CORTISOL KIT received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830148.

Who is the listed applicant for CORTISOL KIT?

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

What is the FDA product code for CORTISOL KIT?

The FDA product code for CORTISOL KIT is CGR.

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Other records listing Cambridge Medical Technology 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.

K890837RIA-GNOST INSULINK890697RIA-GNOST FERRITINK890836RIA-GNOST PROGESTERONEK873737NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAYK870573T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KITK862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL

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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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