Ultraviolet Alanine Amino-Trans (Uv-Alt/Uv-Gpt)
FDA 510(k) K871782 · Biochemical Trade, Inc.
510(k) numberK871782
Submission
- Device name
- Ultraviolet Alanine Amino-Trans (Uv-Alt/Uv-Gpt)
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- May 6, 1987
- Decision date
- May 26, 1987
- 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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| K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special | Dade Behring, Inc. | 05/10/2006SE |
| K020487 | Careside AltCKA · Traditional | Careside, Inc. | 06/04/2002SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | Trace America, Inc. | 02/02/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | Trace America, Inc. | 01/07/1998SE |
| K974003 | Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30CKA · Traditional | Diagnostic Chemicals , Ltd. | 12/05/1997SE |
| K971323 | Alt or SGPTCKA · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
| K965134 | Alt/SgptCKA · Traditional | Derma Media Lab., Inc. | 02/18/1997SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
More from Trace Scientific , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | 11/21/1994SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | 01/30/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
Questions and answers
When was Ultraviolet Alanine Amino-Trans (Uv-Alt/Uv-Gpt) cleared by the FDA?
Ultraviolet Alanine Amino-Trans (Uv-Alt/Uv-Gpt) (K871782) received a 510(k) decision of Substantially Equivalent on May 26, 1987, 20 days after the submission was received.
What is the product code of K871782?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.