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FDA 510(k)

NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE

K-Number: K962601 · 1996-12-24

ApplicantNichols Institute Diagnostics
Decision Date1996-12-24
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1996-12-24 under 510(k) number K962601. 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 NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE?

NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE is a medical device that received FDA 510(k) clearance on 1996-12-24. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K962601.

When did NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE receive FDA 510(k) clearance?

NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE received FDA 510(k) clearance on 1996-12-24, under 510(k) number K962601.

Who is the listed applicant for NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE?

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

What is the FDA product code for NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE?

The FDA product code for NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE is CKG.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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