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FDA 510(k)

KODAK EKTACHEM HDL CHOLESTEROL KIT

K-Number: K854426 · 1986-01-17

ApplicantEastman Kodak Company
Decision Date1986-01-17
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK EKTACHEM HDL CHOLESTEROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1986-01-17 under 510(k) number K854426. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK EKTACHEM HDL CHOLESTEROL KIT?

KODAK EKTACHEM HDL CHOLESTEROL KIT is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Eastman Kodak Company. The 510(k) number is K854426.

When did KODAK EKTACHEM HDL CHOLESTEROL KIT receive FDA 510(k) clearance?

KODAK EKTACHEM HDL CHOLESTEROL KIT received FDA 510(k) clearance on 1986-01-17, under 510(k) number K854426.

Who is the listed applicant for KODAK EKTACHEM HDL CHOLESTEROL KIT?

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

What is the FDA product code for KODAK EKTACHEM HDL CHOLESTEROL KIT?

The FDA product code for KODAK EKTACHEM HDL CHOLESTEROL KIT is CHH.

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Other records listing Eastman Kodak Company as applicant

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K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

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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