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FDA 510(k)

SYNELISA CORTISOL

K-Number: K931177 · 1993-09-27

ApplicantElias U.S.A., Inc.
Decision Date1993-09-27
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNELISA CORTISOL is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1993-09-27 under 510(k) number K931177. 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 SYNELISA CORTISOL?

SYNELISA CORTISOL is a medical device that received FDA 510(k) clearance on 1993-09-27. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K931177.

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

SYNELISA CORTISOL received FDA 510(k) clearance on 1993-09-27, under 510(k) number K931177.

Who is the listed applicant for SYNELISA CORTISOL?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNELISA CORTISOL?

The FDA product code for SYNELISA CORTISOL is CGR.

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Other records listing Elias U.S.A., Inc. 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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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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