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FDA 510(k)

DHEA-S

K-Number: K973897 · 1997-11-13

ApplicantKmi Diagnostics, Inc.
Decision Date1997-11-13
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DHEA-S is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K973897. 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 DHEA-S?

DHEA-S is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Kmi Diagnostics, Inc.. The 510(k) number is K973897.

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

DHEA-S received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973897.

Who is the listed applicant for DHEA-S?

The FDA 510(k) record lists Kmi Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DHEA-S?

The FDA product code for DHEA-S is JKC.

Other records listing Kmi Diagnostics, 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.

K010790CORTISOL LIAK990073CALCITONINK973900TESTOTERONE ELISAK97390117 B-ESTRADIOL (ELISA)K973898PROGESTERONE ELISA

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.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols InstituteK942051SR1 DHEA-S ENZYME IMMUNOASSAYSerono Diagnostics, Inc.

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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