Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) Method
FDA 510(k) K921455 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK921455
Submission
- Device name
- Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) Method
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- March 27, 1992
- Decision date
- April 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) Method cleared by the FDA?
Aca Lactate Dehydrogenase Isoenzyme 1 (LD1) Method (K921455) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 33 days after the submission was received.
What is the product code of K921455?
The FDA product code is CFE – Electrophoretic, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.