Alt/Sgpt
FDA 510(k) K965134 · Derma Media Lab., Inc.
510(k) numberK965134
Submission
- Device name
- Alt/Sgpt
- Applicant
- Derma Media Lab., Inc.
Santa Fe Springs, CA, US - Received
- December 23, 1996
- Decision date
- February 18, 1997
- 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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|---|---|---|---|
| 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 |
| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
| K952427 | CX Alanine, CX Aspartate AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX Creatine…CKA · Traditional | Beckman Instruments, Inc. | 09/21/1995SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971309 | UreaCDQ · Traditional | 08/01/1997SE |
| K970664 | Glucose ReagentCFR · Traditional | 08/01/1997SE |
| K971072 | Cholesterol ReagentCHH · Traditional | 06/20/1997SE |
| K971005 | TriglyceridesJGY · Traditional | 04/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | 04/21/1997SE |
| K964915 | MagnesiumJGJ · Traditional | 03/26/1997SE |
| K964913 | Iron ReagentJIY · Traditional | 02/20/1997SE |
| K964914 | Alkaline PhosphataseCJE · Traditional | 02/04/1997SE |
| K965126 | Ast/SgotCIT · Traditional | 01/17/1997SE |
| K964916 | Gamma-Glutamyl TranspeptidaseJQB · Traditional | 01/10/1997SE |
Questions and answers
When was Alt/Sgpt cleared by the FDA?
Alt/Sgpt (K965134) received a 510(k) decision of Substantially Equivalent on February 18, 1997, 57 days after the submission was received.
What is the product code of K965134?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.