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FDA 510(k)

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS

K-Number: K000900 · 2000-05-02

ApplicantElan Holdings, Inc.
Decision Date2000-05-02
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Elan Holdings, Inc.. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000900. 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 ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS?

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K000900.

When did ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS receive FDA 510(k) clearance?

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000900.

Who is the listed applicant for ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS?

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

What is the FDA product code for ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS?

The FDA product code for ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS is CHH.

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Other records listing Elan Holdings, 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.

K013152ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITSK012474ATAC PAK CPK REAGENT KITK010488ATAC PAK AST REAGENT KITK000958ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSK992842HICHEM ISE ELECTROLYTE REFERENCEK992844HICHEM ISE ELECTROLYTE BUFFER

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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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