Olympus Alanine Aminotransferase Reagent
FDA 510(k) K922884 · Olympus Corp.
510(k) numberK922884
Submission
- Device name
- Olympus Alanine Aminotransferase Reagent
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- June 16, 1992
- Decision date
- July 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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Questions and answers
When was Olympus Alanine Aminotransferase Reagent cleared by the FDA?
Olympus Alanine Aminotransferase Reagent (K922884) received a 510(k) decision of Substantially Equivalent on July 28, 1992, 42 days after the submission was received.
What is the product code of K922884?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.