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FDA 510(k)

CENTRICHEM CHOLESTEROL REAGENT & CALIBRA

K-Number: K812293 · 1981-08-31

ApplicantBaker Diagnostics
Decision Date1981-08-31
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRICHEM CHOLESTEROL REAGENT & CALIBRA is the device name listed in this FDA 510(k) record. The listed applicant is Baker Diagnostics. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812293. 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 CENTRICHEM CHOLESTEROL REAGENT & CALIBRA?

CENTRICHEM CHOLESTEROL REAGENT & CALIBRA is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Baker Diagnostics. The 510(k) number is K812293.

When did CENTRICHEM CHOLESTEROL REAGENT & CALIBRA receive FDA 510(k) clearance?

CENTRICHEM CHOLESTEROL REAGENT & CALIBRA received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812293.

Who is the listed applicant for CENTRICHEM CHOLESTEROL REAGENT & CALIBRA?

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

What is the FDA product code for CENTRICHEM CHOLESTEROL REAGENT & CALIBRA?

The FDA product code for CENTRICHEM CHOLESTEROL REAGENT & CALIBRA is CHH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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