Sigma Diagnostics Accuclot Control I
FDA 510(k) K981248 · Sigma Diagnostics, Inc.
510(k) numberK981248
Submission
- Device name
- Sigma Diagnostics Accuclot Control I
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- April 6, 1998
- Decision date
- April 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- 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 Control I cleared by the FDA?
Sigma Diagnostics Accuclot Control I (K981248) received a 510(k) decision of Substantially Equivalent on April 29, 1998, 23 days after the submission was received.
What is the product code of K981248?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.