Reaads Monoclonal Free Protein S Antigen Test Kit
FDA 510(k) K983914 · Corgenix, Inc.
510(k) numberK983914
Submission
- Device name
- Reaads Monoclonal Free Protein S Antigen Test Kit
- Applicant
- Corgenix, Inc.
Westminster, CO, US - Received
- November 4, 1998
- Decision date
- December 22, 1998
- 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 Reaads Monoclonal Free Protein S Antigen Test Kit cleared by the FDA?
Reaads Monoclonal Free Protein S Antigen Test Kit (K983914) received a 510(k) decision of Substantially Equivalent on December 22, 1998, 48 days after the submission was received.
What is the product code of K983914?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.