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FDA 510(k)

ATAC PAK ALP REAGENT KIT

K-Number: K002285 · 2000-09-26

ApplicantElan Diagnostics
Decision Date2000-09-26
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK ALP REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K002285. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK ALP REAGENT KIT?

ATAC PAK ALP REAGENT KIT is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Elan Diagnostics. The 510(k) number is K002285.

When did ATAC PAK ALP REAGENT KIT receive FDA 510(k) clearance?

ATAC PAK ALP REAGENT KIT received FDA 510(k) clearance on 2000-09-26, under 510(k) number K002285.

Who is the listed applicant for ATAC PAK ALP REAGENT KIT?

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

What is the FDA product code for ATAC PAK ALP REAGENT KIT?

The FDA product code for ATAC PAK ALP REAGENT KIT is CJE.

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Other records listing Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030006ATAC PAK ALBUMIN REAGENT

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Related Devices (Code: CJE)

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.

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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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