Lactate Dehydrogenase Colorimetric Sub.
FDA 510(k) K780080 · Corning Medical & Scientific
510(k) numberK780080
Submission
- Device name
- Lactate Dehydrogenase Colorimetric Sub.
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- January 16, 1978
- Decision date
- February 7, 1978
- 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 Lactate Dehydrogenase Colorimetric Sub. cleared by the FDA?
Lactate Dehydrogenase Colorimetric Sub. (K780080) received a 510(k) decision of Substantially Equivalent on February 7, 1978, 22 days after the submission was received.
What is the product code of K780080?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.