Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin
FDA 510(k) K023362 · Fisher Diagnostics
510(k) numberK023362
Submission
- Device name
- Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin
- Applicant
- Fisher Diagnostics
Middletown, VA, US - Received
- October 7, 2002
- Decision date
- December 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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Questions and answers
When was Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin cleared by the FDA?
Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin (K023362) received a 510(k) decision of Substantially Equivalent on December 9, 2002, 63 days after the submission was received.
What is the product code of K023362?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.