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SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020467
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2002
Days to Decision
45 days
Submission Type
Statement

SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020467
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2002
Days to Decision
45 days
Submission Type
Statement