Alanine Aminotransferase Reagent System
FDA 510(k) K952744 · Medical Diagnostic Technologies, Inc.
510(k) numberK952744
Submission
- Device name
- Alanine Aminotransferase Reagent System
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- June 16, 1995
- Decision date
- August 7, 1995
- 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 Alanine Aminotransferase Reagent System cleared by the FDA?
Alanine Aminotransferase Reagent System (K952744) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 52 days after the submission was received.
What is the product code of K952744?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.