Alanine Transaminase (Alt) Test Kit
FDA 510(k) K870879 · Genetic Systems Corp.
510(k) numberK870879
Submission
- Device name
- Alanine Transaminase (Alt) Test Kit
- Applicant
- Genetic Systems Corp.
Seattle, WA, US - Received
- March 4, 1987
- Decision date
- March 19, 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
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 |
|---|---|---|
| K891767 | Genetic Systems Microplate ReaderJJQ · Traditional | 07/25/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | 05/01/1989SE |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | 03/21/1989SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | 09/23/1987SE |
| K870176 | Genetic Systems RSV Immunofluorescence Test KitLKT · Traditional | 07/16/1987SE |
| K863566 | GSC 1000JJQ · Traditional | 10/16/1986SE |
| K852237 | Legionella Immunofluorescent Antibody Test KitLHL · Traditional | 08/22/1985SE |
Questions and answers
When was Alanine Transaminase (Alt) Test Kit cleared by the FDA?
Alanine Transaminase (Alt) Test Kit (K870879) received a 510(k) decision of Substantially Equivalent on March 19, 1987, 15 days after the submission was received.
What is the product code of K870879?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.