Optimized Uv-Gpt Reagent Set
FDA 510(k) K822494 · Biorent Diagnostic, Inc.
510(k) numberK822494
Submission
- Device name
- Optimized Uv-Gpt Reagent Set
- Applicant
- Biorent Diagnostic, Inc.
Mchenry, IL, US - Received
- August 18, 1982
- Decision date
- September 21, 1982
- 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 |
|---|---|---|
| K832747 | Albumin Reagent SetCIX · Traditional | 10/14/1983SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | 11/22/1982SE |
| K823060 | Hemoglobin ReagentKHG · Traditional | 11/22/1982SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | 09/21/1982SE |
| K822492 | Optimized Uv-Ldh Reagent SetCFJ · Traditional | 09/17/1982SE |
| K820768 | Colorimetric LDH Reagent SetCFH · Traditional | 04/14/1982SE |
| K820632 | Colorimetric Uric Acid Reagent SetKNK · Traditional | 03/25/1982SE |
| K813555 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 01/18/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | 12/08/1981SE |
| K811760 | Cholesterol DeterminationCHH · Traditional | 07/10/1981SE |
Questions and answers
When was Optimized Uv-Gpt Reagent Set cleared by the FDA?
Optimized Uv-Gpt Reagent Set (K822494) received a 510(k) decision of Substantially Equivalent on September 21, 1982, 34 days after the submission was received.
What is the product code of K822494?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.