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FDA 510(k)

SYNELISA DHEA-SULFATE

K-Number: K935469 · 1994-03-22

ApplicantElias U.S.A., Inc.
Decision Date1994-03-22
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNELISA DHEA-SULFATE 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 1994-03-22 under 510(k) number K935469. The device is classified under product code JKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA DHEA-SULFATE?

SYNELISA DHEA-SULFATE is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K935469.

When did SYNELISA DHEA-SULFATE receive FDA 510(k) clearance?

SYNELISA DHEA-SULFATE received FDA 510(k) clearance on 1994-03-22, under 510(k) number K935469.

Who is the listed applicant for SYNELISA DHEA-SULFATE?

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 DHEA-SULFATE?

The FDA product code for SYNELISA DHEA-SULFATE is JKC.

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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: JKC)

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.

K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.K003174ELECSYS DHEA-SRoche Diagnostics Corp.K973897DHEA-SKmi Diagnostics, Inc.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols Institute

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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