Spectrolyse PAI-1, Model 101201
FDA 510(k) K063323 · American Diagnostica, Inc.
510(k) numberK063323
Submission
- Device name
- Spectrolyse PAI-1, Model 101201
- Applicant
- American Diagnostica, Inc.
Stamford, CT, US - Received
- November 3, 2006
- Decision date
- August 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Spectrolyse PAI-1, Model 101201 cleared by the FDA?
Spectrolyse PAI-1, Model 101201 (K063323) received a 510(k) decision of Substantially Equivalent on August 15, 2007, 285 days after the submission was received.
What is the product code of K063323?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.