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FDA 510(k)

ATAC PAK AST REAGENT KIT

K-Number: K010488 · 2001-04-09

ApplicantElan Holdings, Inc.
Decision Date2001-04-09
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK AST 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 2001-04-09 under 510(k) number K010488. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK AST REAGENT KIT?

ATAC PAK AST REAGENT KIT is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K010488.

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

ATAC PAK AST REAGENT KIT received FDA 510(k) clearance on 2001-04-09, under 510(k) number K010488.

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

The FDA product code for ATAC PAK AST REAGENT KIT is CIT.

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Other records listing Elan Holdings, Inc. as applicant

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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