Alt Reagent
FDA 510(k) K800038 · Gilford Diagnostics
510(k) numberK800038
Submission
- Device name
- Alt Reagent
- Applicant
- Gilford Diagnostics
Mchenry, IL, US - Received
- January 7, 1980
- Decision date
- January 21, 1980
- 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 |
|---|---|---|
| K832094 | Bilirubin Calibrators & ControlJIT · Traditional | 08/11/1983SE |
| K831844 | Direct Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K831843 | Gilchem Total Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K823709 | Triglyceride Reagent (UV)CDT · Traditional | 01/07/1983SE |
| K822739 | AhbdJMK · Traditional | 10/18/1982SE |
| K822334 | Bilirubin CalibratorsJIT · Traditional | 09/02/1982SE |
| K822289 | CO2/CI StandardsJIX · Traditional | 08/24/1982SE |
| K822149 | Gilchem Y-Gt ReagentJPZ · Traditional | 08/12/1982SE |
| K821719 | Ammonia ReagentJIF · Traditional | 06/24/1982SE |
| K820976 | Gil Chem Magnesium ReagentJGJ · Traditional | 04/26/1982SE |
Questions and answers
When was Alt Reagent cleared by the FDA?
Alt Reagent (K800038) received a 510(k) decision of Substantially Equivalent on January 21, 1980, 14 days after the submission was received.
What is the product code of K800038?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.