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ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000958
510(k) Type
Traditional
Applicant
ELAN HOLDINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2000
Days to Decision
61 days
Submission Type
Summary

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000958
510(k) Type
Traditional
Applicant
ELAN HOLDINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2000
Days to Decision
61 days
Submission Type
Summary