Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560
FDA 510(k) K010750 · Fisher Diagnostics
510(k) numberK010750
Submission
- Device name
- Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560
- Applicant
- Fisher Diagnostics
Middletown, VA, US - Received
- March 13, 2001
- Decision date
- September 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560 cleared by the FDA?
Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560 (K010750) received a 510(k) decision of Substantially Equivalent on September 7, 2001, 178 days after the submission was received.
What is the product code of K010750?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.