Impact 400 #1447X2
FDA 510(k) K833067 · Gilford
510(k) numberK833067
Submission
- Device name
- Impact 400 #1447X2
- Applicant
- Gilford
Mchenry, IL, US - Received
- September 8, 1983
- Decision date
- December 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…JJE · Traditional | Horiba, Ltd. | 02/12/2019SE |
| K133519 | Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional | Carolina Liquid Chemistries Corp. | 05/16/2014SE |
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | Jas Diagnostics, Inc. | 05/15/2014SE |
| K131554 | RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast)…JJE · Traditional | Randox Laboratories, Ltd. | 01/09/2014SE |
| K130276 | Dimension Exl with LM SystemJJE · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/22/2013SE |
| K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…JJE · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 05/17/2012SE |
| K112999 | Dimension Clinical Chemistry SystemJJE · Special | Siemens Healthcare Diagnostics | 11/22/2011SE |
| K110035 | IndikoJJE · Traditional | Thermofisher Scientific OY | 06/28/2011SE |
| K073370 | TC Matrix Clinical Chemistry AnalyzerJJE · Traditional | Teco Diagnostics | 05/08/2008SE |
| K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemJJE · Special | Ortho-Clinical Diagnostics, Inc. | 11/13/2006SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853469 | Gilford Immunoglobulin M ReagentDFT · Traditional | 09/16/1985SE |
| K853468 | Gilford C4 Complement ReagentDBI · Traditional | 09/16/1985SE |
| K853467 | Gilford Immunoglobulin a ReagentCZP · Traditional | 09/16/1985SE |
| K853466 | Gilford C3 Complement ReagentCZW · Traditional | 09/16/1985SE |
| K853465 | Gilford Immunoglobulin G ReagentDEW · Traditional | 09/16/1985SE |
| K851202 | Gilford Tri-Level Assayed Immunology ControlDAK · Traditional | 04/29/1985SE |
| K842500 | Data Mgmt. SystemJJE · Traditional | 08/16/1984SE |
| K840120 | AdvantageJJE · Traditional | 03/23/1984SE |
| K812787 | Eia RubellaLFX · Traditional | 11/27/1981SE |
Questions and answers
When was Impact 400 #1447X2 cleared by the FDA?
Impact 400 #1447X2 (K833067) received a 510(k) decision of Substantially Equivalent on December 8, 1983, 91 days after the submission was received.
What is the product code of K833067?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.