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FDA 510(k)

GAMMA STICK CORTISOL RIA KIT/STICK KIT

K-Number: K800538 · 1980-04-24

ApplicantAlpha Gamma Laboratory
Decision Date1980-04-24
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA STICK CORTISOL RIA KIT/STICK KIT is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Gamma Laboratory. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800538. 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 GAMMA STICK CORTISOL RIA KIT/STICK KIT?

GAMMA STICK CORTISOL RIA KIT/STICK KIT is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Alpha Gamma Laboratory. The 510(k) number is K800538.

When did GAMMA STICK CORTISOL RIA KIT/STICK KIT receive FDA 510(k) clearance?

GAMMA STICK CORTISOL RIA KIT/STICK KIT received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800538.

Who is the listed applicant for GAMMA STICK CORTISOL RIA KIT/STICK KIT?

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

What is the FDA product code for GAMMA STICK CORTISOL RIA KIT/STICK KIT?

The FDA product code for GAMMA STICK CORTISOL RIA KIT/STICK KIT is CGR.

Related Clinical Trials

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.

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Other records listing Alpha Gamma Laboratory 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.

K810011GAMMA STICK 125-1 TOBRAMYCIN RIA KITK800537GAMMA STICK GENTAMICIN RIA KITK780492GAMMA STIK 125I T3 UPTAKE KIT

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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