Last synced on 27 June 2025 at 11:06 pm

SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992803
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/1999
Days to Decision
25 days
Submission Type
Summary

SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992803
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/1999
Days to Decision
25 days
Submission Type
Summary