DC-3 Fluids Pack, DC-5 Fluids Pack
FDA 510(k) K852595 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK852595
Submission
- Device name
- DC-3 Fluids Pack, DC-5 Fluids Pack
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Charlottestown,Pei,Canada, CA - Received
- June 19, 1985
- Decision date
- July 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | 08/23/2002SE |
| K974874 | Bilirubin-Sl (Total) AssayCIG · Traditional | 02/12/1998SE |
| K932556 | Ammonia Assay Cat. No. 200-02JIF · Traditional | 08/02/1994SE |
| K932766 | Hdl-Cholestral(Dextran Sulfate/Magnesium)LBR · Traditional | 12/10/1993SE |
| K932555 | Dc-Lineate Cat. No. SE-091JIS · Traditional | 08/19/1993SE |
| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
| K904660 | Enzymatic Bilirubin (Total), Catalogue No. 202-14JFM · Traditional | 11/20/1990SE |
Questions and answers
When was DC-3 Fluids Pack, DC-5 Fluids Pack cleared by the FDA?
DC-3 Fluids Pack, DC-5 Fluids Pack (K852595) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 23 days after the submission was received.
What is the product code of K852595?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.