Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent Set
FDA 510(k) K860110 · Technostics Intl.
510(k) numberK860110
Submission
- Device name
- Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent Set
- Applicant
- Technostics Intl.
Washington, MI, US - Received
- January 13, 1986
- Decision date
- February 11, 1986
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K855188 | CPK (UV) Reagent KitJHS · Traditional | 03/05/1986SE |
| K860111 | Uric Acid Reagent SetLFQ · Traditional | 02/19/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | 02/18/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 02/06/1986SE |
| K860112 | Total Lipids Reagent SetCFD · Traditional | 01/24/1986SE |
| K855185 | Glucose Reagent SetCGE · Traditional | 01/22/1986SE |
| K855157 | Lactic Dehydrogenase (VV) Reagent SetCFJ · Traditional | 01/21/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | 01/14/1986SE |
| K855194 | Glucose Oxidase Reagent SetCGA · Traditional | 01/14/1986SE |
| K855193 | Creatinine Reagent SetCGX · Traditional | 01/14/1986SE |
Questions and answers
When was Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent Set cleared by the FDA?
Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent Set (K860110) received a 510(k) decision of Substantially Equivalent on February 11, 1986, 29 days after the submission was received.
What is the product code of K860110?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.