Transphor TM LD Lactate Dehydrogenase
FDA 510(k) K800568 · Corning Medical & Scientific
510(k) numberK800568
Submission
- Device name
- Transphor TM LD Lactate Dehydrogenase
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- March 13, 1980
- Decision date
- April 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Transphor TM LD Lactate Dehydrogenase cleared by the FDA?
Transphor TM LD Lactate Dehydrogenase (K800568) received a 510(k) decision of Substantially Equivalent on April 4, 1980, 22 days after the submission was received.
What is the product code of K800568?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.