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FDA 510(k)

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT

K-Number: K870828 · 1987-03-13

ApplicantIntersect Systems, Inc.
Decision Date1987-03-13
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K870828. 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 INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT?

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K870828.

When did INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT receive FDA 510(k) clearance?

INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870828.

Who is the listed applicant for INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT?

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

What is the FDA product code for INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT?

The FDA product code for INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT is CHH.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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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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