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FDA 510(k)

BIOTROL CHOLESTEROL ENZYMATIQUE COLOR

K-Number: K872930 · 1987-08-21

ApplicantBiotrol, USA, Inc.
Decision Date1987-08-21
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL CHOLESTEROL ENZYMATIQUE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1987-08-21 under 510(k) number K872930. 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 BIOTROL CHOLESTEROL ENZYMATIQUE COLOR?

BIOTROL CHOLESTEROL ENZYMATIQUE COLOR is a medical device that received FDA 510(k) clearance on 1987-08-21. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K872930.

When did BIOTROL CHOLESTEROL ENZYMATIQUE COLOR receive FDA 510(k) clearance?

BIOTROL CHOLESTEROL ENZYMATIQUE COLOR received FDA 510(k) clearance on 1987-08-21, under 510(k) number K872930.

Who is the listed applicant for BIOTROL CHOLESTEROL ENZYMATIQUE COLOR?

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

What is the FDA product code for BIOTROL CHOLESTEROL ENZYMATIQUE COLOR?

The FDA product code for BIOTROL CHOLESTEROL ENZYMATIQUE COLOR is CHH.

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Other records listing Biotrol, USA, Inc. as applicant

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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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