ACTICLOT PROTEIN S, MODEL 843L— 510(k) K012386
Substantially EquivalentAmerican Diagnostica, Inc.
FDA 510(k) clearance K012386 for ACTICLOT PROTEIN S, MODEL 843L, Substantially Equivalent on 2001-09-14. Applicant: American Diagnostica, Inc.. Device class: 2.
Clearance details
- Applicant
- American Diagnostica, Inc.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwich, CT, US
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