Sigma Diagnostics Accuclot la Control
FDA 510(k) K020109 · Sigma Diagnostics, Inc.
510(k) numberK020109
Submission
- Device name
- Sigma Diagnostics Accuclot la Control
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- January 11, 2002
- Decision date
- February 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Sigma Diagnostics Accuclot la Control cleared by the FDA?
Sigma Diagnostics Accuclot la Control (K020109) received a 510(k) decision of Substantially Equivalent on February 6, 2002, 26 days after the submission was received.
What is the product code of K020109?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.