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FDA 510(k)

CHOLESTEZYME-V EIKEN

K-Number: K821105 · 1982-05-05

ApplicantSyn-Kit, Inc.
Decision Date1982-05-05
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEZYME-V EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1982-05-05 under 510(k) number K821105. 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 CHOLESTEZYME-V EIKEN?

CHOLESTEZYME-V EIKEN is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K821105.

When did CHOLESTEZYME-V EIKEN receive FDA 510(k) clearance?

CHOLESTEZYME-V EIKEN received FDA 510(k) clearance on 1982-05-05, under 510(k) number K821105.

Who is the listed applicant for CHOLESTEZYME-V EIKEN?

The FDA 510(k) record lists Syn-Kit, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEZYME-V EIKEN?

The FDA product code for CHOLESTEZYME-V EIKEN is CHH.

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Other records listing Syn-Kit, Inc. 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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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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