Protein C Reagent
FDA 510(k) K002541 · Dade Behring, Inc.
510(k) numberK002541
Submission
- Device name
- Protein C Reagent
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- August 16, 2000
- Decision date
- September 26, 2000
- 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 Protein C Reagent cleared by the FDA?
Protein C Reagent (K002541) received a 510(k) decision of Substantially Equivalent on September 26, 2000, 41 days after the submission was received.
What is the product code of K002541?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.