ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589— 510(k) K982209
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K982209 for ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589, Substantially Equivalent on 1998-10-15. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code GJA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7875
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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