SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

K003267 · Sigma Diagnostics, Inc. · DAP · Mar 15, 2001 · Hematology

Device Facts

• Record ID: K003267
• Device Name: SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
• Applicant: Sigma Diagnostics, Inc.
• Product Code: DAP · Hematology
• Decision Date: Mar 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2