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BUN(ENDPOINT) REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852131
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/1985
Days to Decision
25 days

BUN(ENDPOINT) REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852131
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/1985
Days to Decision
25 days