Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh Kit
FDA 510(k) K970477 · Sebia
510(k) numberK970477
Submission
- Device name
- Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh Kit
- Applicant
- Sebia
Chelsea, MI, US - Received
- February 7, 1997
- Decision date
- March 10, 1997
- 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 Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh Kit cleared by the FDA?
Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh Kit (K970477) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 31 days after the submission was received.
What is the product code of K970477?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.