Ultrazyme Plus LDH, #64950,65038&65039
FDA 510(k) K821466 · Emd Chemicals, Inc.
510(k) numberK821466
Submission
- Device name
- Ultrazyme Plus LDH, #64950,65038&65039
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- June 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ultrazyme Plus LDH, #64950,65038&65039 cleared by the FDA?
Ultrazyme Plus LDH, #64950,65038&65039 (K821466) received a 510(k) decision of Substantially Equivalent on June 1, 1982, 14 days after the submission was received.
What is the product code of K821466?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.