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FDA 510(k)

CHEMILUMINESCENCE DHEA-S IMMUNOASSAY

K-Number: K931601 · 1993-07-27

ApplicantNichols Institute
Decision Date1993-07-27
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMILUMINESCENCE DHEA-S IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K931601. 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 CHEMILUMINESCENCE DHEA-S IMMUNOASSAY?

CHEMILUMINESCENCE DHEA-S IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Nichols Institute. The 510(k) number is K931601.

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

CHEMILUMINESCENCE DHEA-S IMMUNOASSAY received FDA 510(k) clearance on 1993-07-27, under 510(k) number K931601.

Who is the listed applicant for CHEMILUMINESCENCE DHEA-S IMMUNOASSAY?

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

What is the FDA product code for CHEMILUMINESCENCE DHEA-S IMMUNOASSAY?

The FDA product code for CHEMILUMINESCENCE DHEA-S IMMUNOASSAY is JKC.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

View all 15 devices →

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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