ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119— 510(k) K000528
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K000528 for ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119, Substantially Equivalent on 2000-04-07. Applicant: Sigma Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code GIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.8950
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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