Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)
FDA 510(k) K980028 · Trace America, Inc.
510(k) numberK980028
Submission
- Device name
- Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- January 5, 1998
- Decision date
- February 2, 1998
- 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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| K980030 | Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CIT · Traditional | 01/30/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | 01/07/1998SE |
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| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | 05/27/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | 05/27/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | 03/13/1997SE |
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Questions and answers
When was Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) cleared by the FDA?
Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) (K980028) received a 510(k) decision of Substantially Equivalent on February 2, 1998, 28 days after the submission was received.
What is the product code of K980028?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.