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FDA 510(k)

EMIT SRD MANUAL CORTISOL ASSAY

K-Number: K831141 · 1983-05-27

ApplicantSyva Co.
Decision Date1983-05-27
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT SRD MANUAL CORTISOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1983-05-27 under 510(k) number K831141. 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 EMIT SRD MANUAL CORTISOL ASSAY?

EMIT SRD MANUAL CORTISOL ASSAY is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Syva Co.. The 510(k) number is K831141.

When did EMIT SRD MANUAL CORTISOL ASSAY receive FDA 510(k) clearance?

EMIT SRD MANUAL CORTISOL ASSAY received FDA 510(k) clearance on 1983-05-27, under 510(k) number K831141.

Who is the listed applicant for EMIT SRD MANUAL CORTISOL ASSAY?

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

What is the FDA product code for EMIT SRD MANUAL CORTISOL ASSAY?

The FDA product code for EMIT SRD MANUAL CORTISOL ASSAY is CGR.

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Other records listing Syva 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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