Technicon Dax TM System Additional Analytes
FDA 510(k) K892930 · Technicon Instruments Corp.
510(k) numberK892930
Submission
- Device name
- Technicon Dax TM System Additional Analytes
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- April 21, 1989
- Decision date
- July 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Technicon Dax TM System Additional Analytes cleared by the FDA?
Technicon Dax TM System Additional Analytes (K892930) received a 510(k) decision of Substantially Equivalent on July 27, 1989, 97 days after the submission was received.
What is the product code of K892930?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.