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FDA 510(k)

ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT

K-Number: K926396 · 1993-07-27

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

Device Summary

ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT 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 K926396. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT?

ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT 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 K926396.

When did ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT receive FDA 510(k) clearance?

ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT received FDA 510(k) clearance on 1993-07-27, under 510(k) number K926396.

Who is the listed applicant for ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT?

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 ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT?

The FDA product code for ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT is CKG.

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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

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Related Devices (Code: CKG)

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.

K223867IDS ACTH IIImmunodiagnostic Systems LimitedK111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.

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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