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FDA 510(k)

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

K-Number: K000958 · 2000-05-24

ApplicantElan Holdings, Inc.
Decision Date2000-05-24
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR 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 2000-05-24 under 510(k) number K000958. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS?

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS is a medical device that received FDA 510(k) clearance on 2000-05-24. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K000958.

When did ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS receive FDA 510(k) clearance?

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS received FDA 510(k) clearance on 2000-05-24, under 510(k) number K000958.

Who is the listed applicant for ATAC PAK BUN REAGENT AND ATAC CALIBRATOR 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 BUN REAGENT AND ATAC CALIBRATOR KITS?

The FDA product code for ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS is CDQ.

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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 KITK000900ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITSK992842HICHEM ISE ELECTROLYTE REFERENCEK992844HICHEM ISE ELECTROLYTE BUFFER

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Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, 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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