Alanine Aminotransferase Assay Kit
FDA 510(k) K842241 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK842241
Submission
- Device name
- Alanine Aminotransferase Assay Kit
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Canada, US - Received
- June 5, 1984
- Decision date
- July 18, 1984
- 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
Other 510(k)s with product code CKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K113382 | Ace Alt ReagentCKA · Traditional | Alfa Wassermann | 07/19/2012SE |
| 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 |
|---|---|---|
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | 08/23/2002SE |
| K974874 | Bilirubin-Sl (Total) AssayCIG · Traditional | 02/12/1998SE |
| K932556 | Ammonia Assay Cat. No. 200-02JIF · Traditional | 08/02/1994SE |
| K932766 | Hdl-Cholestral(Dextran Sulfate/Magnesium)LBR · Traditional | 12/10/1993SE |
| K932555 | Dc-Lineate Cat. No. SE-091JIS · Traditional | 08/19/1993SE |
| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
| K904660 | Enzymatic Bilirubin (Total), Catalogue No. 202-14JFM · Traditional | 11/20/1990SE |
Questions and answers
When was Alanine Aminotransferase Assay Kit cleared by the FDA?
Alanine Aminotransferase Assay Kit (K842241) received a 510(k) decision of Substantially Equivalent on July 18, 1984, 43 days after the submission was received.
What is the product code of K842241?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.