Gelscan, Model 1206
FDA 510(k) K100307 · Sebia
510(k) numberK100307
Submission
- Device name
- Gelscan, Model 1206
- Applicant
- Sebia
Norcross, GA, US - Received
- February 3, 2010
- Decision date
- August 31, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Specialty
- Clinical Chemistry
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Questions and answers
When was Gelscan, Model 1206 cleared by the FDA?
Gelscan, Model 1206 (K100307) received a 510(k) decision of Substantially Equivalent on August 31, 2010, 209 days after the submission was received.
What is the product code of K100307?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.