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FDA 510(k)

ATAC PAK CPK REAGENT KIT

K-Number: K012474 · 2001-10-03

ApplicantElan Holdings, Inc.
Decision Date2001-10-03
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK CPK REAGENT KIT 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 2001-10-03 under 510(k) number K012474. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK CPK REAGENT KIT?

ATAC PAK CPK REAGENT KIT is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K012474.

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

ATAC PAK CPK REAGENT KIT received FDA 510(k) clearance on 2001-10-03, under 510(k) number K012474.

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

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 CPK REAGENT KIT?

The FDA product code for ATAC PAK CPK REAGENT KIT is CGS.

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Other records listing Elan Holdings, Inc. as applicant

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Related Devices (Code: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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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