LDH Clini Gel Kit
FDA 510(k) K791827 · Clinical Sciences, Inc.
510(k) numberK791827
Submission
- Device name
- LDH Clini Gel Kit
- Applicant
- Clinical Sciences, Inc.
Mchenry, IL, US - Received
- September 17, 1979
- Decision date
- October 1, 1979
- 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 LDH Clini Gel Kit cleared by the FDA?
LDH Clini Gel Kit (K791827) received a 510(k) decision of Substantially Equivalent on October 1, 1979, 14 days after the submission was received.
What is the product code of K791827?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.