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FDA 510(k)

IMMPULSE CORTISOL ASSAY REAGENTS

K-Number: K842554 · 1984-08-12

ApplicantAktis Corp.
Decision Date1984-08-12
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMPULSE CORTISOL ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Aktis Corp.. It received FDA 510(k) clearance on 1984-08-12 under 510(k) number K842554. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE CORTISOL ASSAY REAGENTS?

IMMPULSE CORTISOL ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is Aktis Corp.. The 510(k) number is K842554.

When did IMMPULSE CORTISOL ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE CORTISOL ASSAY REAGENTS received FDA 510(k) clearance on 1984-08-12, under 510(k) number K842554.

Who is the listed applicant for IMMPULSE CORTISOL ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE CORTISOL ASSAY REAGENTS?

The FDA product code for IMMPULSE CORTISOL ASSAY REAGENTS is CGR.

Related Clinical Trials

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Other records listing Aktis Corp. 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.

K842571IMMPULSE DIGOXIN ASSAY REAGENTS

Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

Official Source

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