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FDA 510(k)

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD

K-Number: K864159 · 1988-06-10

ApplicantChem-Elec, Inc.
Decision Date1988-06-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Chem-Elec, Inc.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K864159. 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 SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD?

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Chem-Elec, Inc.. The 510(k) number is K864159.

When did SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD receive FDA 510(k) clearance?

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD received FDA 510(k) clearance on 1988-06-10, under 510(k) number K864159.

Who is the listed applicant for SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD?

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

What is the FDA product code for SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD?

The FDA product code for SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD is CHH.

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Other records listing Chem-Elec, 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.

K943503CHEMCARD GLUCOSE TESTK811319CHLORIDE REAGENT KITK811381ASTRAK811406CREATININE RATE REAGENT KITK811165GLUCOSE OXIDASE RATE REAGENTK811310SODIUM/POTASSIUM REAGENT KITS

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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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