Reagent for Determ. Creatinine in H/Seru
FDA 510(k) K800685 · Diagnostic Solutions, Inc.
510(k) numberK800685
Submission
- Device name
- Reagent for Determ. Creatinine in H/Seru
- Applicant
- Diagnostic Solutions, Inc.
Mchenry, IL, US - Received
- March 26, 1980
- Decision date
- May 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGX – Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 01/09/2026SE |
| K251058 | Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional | Truvian Health | 11/26/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 11/19/2024SE |
| K210452 | Creatinine2CGX · Traditional | Abbott Ireland Diagnostics Division | 03/22/2022SE |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/15/2016SE |
| K132638 | Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/27/2014SE |
| K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/24/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | Medica Corporation | 05/15/2013SE |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated | Horiba Abx SAS | 04/30/2012SE |
More from Horiba Abx SAS
| 510(k) | Device | Decision |
|---|---|---|
| K934892 | Relief Plus One Reagent Strip ModificationCGA · Traditional | 01/11/1994SE |
| K924398 | Uni-Check Reagent StripCGA · Traditional | 12/23/1992SE |
| K921825 | Quick-Check II Reagent StripCGA · Traditional | 08/18/1992SE |
| K800689 | Reagent for Determ. Glutamic-Pyruvic-CKA · Traditional | 05/30/1980SE |
| K800681 | Reagents for Determ. CO2 in Human SerumKMS · Traditional | 05/30/1980SE |
| K800692 | Reagent for Determ. Potassium/In HumanCEM · Traditional | 05/28/1980SE |
| K800691 | Reagent for Determ. Lactate/DehydrogenasCFJ · Traditional | 05/28/1980SE |
| K800690 | Reagent for Determ. Inorganic/PhosphorusCEO · Traditional | 05/28/1980SE |
| K800688 | Reagent for Determ. Glutamic-OxaloaceticCIT · Traditional | 05/28/1980SE |
| K800687 | Reagent for Determ. Glucose in H/SerumCGA · Traditional | 05/28/1980SE |
Questions and answers
When was Reagent for Determ. Creatinine in H/Seru cleared by the FDA?
Reagent for Determ. Creatinine in H/Seru (K800685) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 63 days after the submission was received.
What is the product code of K800685?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.