Last synced on 24 March 2023 at 11:04 pm

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992800
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/1999
Days to Decision
40 days
Submission Type
Summary

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992800
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/1999
Days to Decision
40 days
Submission Type
Summary