PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560— 510(k) K010750
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K010750 for PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560, Substantially Equivalent on 2001-09-07. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher Diagnostics
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middletown, VA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.