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FDA 510(k)

LINEAR ENZYMATIC CHOLESTEROL SYSTEM

K-Number: K800199 · 1980-02-21

ApplicantSimmler, Inc.
Decision Date1980-02-21
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINEAR ENZYMATIC CHOLESTEROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K800199. 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 LINEAR ENZYMATIC CHOLESTEROL SYSTEM?

LINEAR ENZYMATIC CHOLESTEROL SYSTEM is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Simmler, Inc.. The 510(k) number is K800199.

When did LINEAR ENZYMATIC CHOLESTEROL SYSTEM receive FDA 510(k) clearance?

LINEAR ENZYMATIC CHOLESTEROL SYSTEM received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800199.

Who is the listed applicant for LINEAR ENZYMATIC CHOLESTEROL SYSTEM?

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

What is the FDA product code for LINEAR ENZYMATIC CHOLESTEROL SYSTEM?

The FDA product code for LINEAR ENZYMATIC CHOLESTEROL SYSTEM is CHH.

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Other records listing Simmler, Inc. as applicant

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K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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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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