Asserachrom Hpia Test Kit
FDA 510(k) K003767 · Diagnostica Stago, Inc.
510(k) numberK003767
Submission
- Device name
- Asserachrom Hpia Test Kit
- Applicant
- Diagnostica Stago, Inc.
Parsippany, NJ, US - Received
- December 6, 2000
- Decision date
- February 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCO – Platelet Factor 4 Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7695
- Specialty
- Hematology
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Questions and answers
When was Asserachrom Hpia Test Kit cleared by the FDA?
Asserachrom Hpia Test Kit (K003767) received a 510(k) decision of Substantially Equivalent on February 12, 2001, 68 days after the submission was received.
What is the product code of K003767?
The FDA product code is LCO – Platelet Factor 4 Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 864.7695.