Ld-L Tris System Pack Test
FDA 510(k) K820378 · Boehringer Mannheim Corp.
510(k) numberK820378
Submission
- Device name
- Ld-L Tris System Pack Test
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- February 9, 1982
- Decision date
- March 8, 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 Ld-L Tris System Pack Test cleared by the FDA?
Ld-L Tris System Pack Test (K820378) received a 510(k) decision of Substantially Equivalent on March 8, 1982, 27 days after the submission was received.
What is the product code of K820378?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.