Synermed Ir 500 Chemistry Analyzer
FDA 510(k) K935662 · Synermed, Inc.
510(k) numberK935662
Submission
- Device name
- Synermed Ir 500 Chemistry Analyzer
- Applicant
- Synermed, Inc.
Quebec, Canada, CA - Received
- November 26, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141925 | Total Protein Urine/Csf GEN.3JIQ · Special | Roche Diagnostics Operations (Rdo) | 12/09/2014SE |
| K013643 | Ausam Total Albumin AssayJIQ · Traditional | Ausam Biotecthnologies, Inc. | 08/14/2003SE |
| K991800 | Hemochek Urine Collection KitJIQ · Traditional | Osborn Group, Inc. | 09/24/1999SE |
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | Diagnostic Specialties | 09/02/1997SE |
| K965035 | Immage Immunochemistry System Microalbumin (Ma) ReagentJIQ · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
| K944664 | Wako Micro-Albumin B/Wako Micro Albumin CalibratorJIQ · Traditional | Wako Chemicals USA, Inc. | 02/07/1995SE |
| K936202 | Urinary Albumin Test PackJIQ · Traditional | Dupont Medical Products | 05/09/1994SE |
| K903123 | Raichem(Tm) Spia(Tm) Microalbulmin ReagentJIQ · Traditional | Reagents Applications, Inc. | 09/14/1990SE |
| K902216 | Wako(Tm) Micro-AlbuminJIQ · Traditional | Wako Chemicals USA, Inc. | 06/18/1990SE |
| K895883 | Beckman Ma Microalbumin Reagent KitJIQ · Traditional | Beckman Instruments, Inc. | 12/27/1989SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973109 | Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional | 09/25/1997SE |
| K972716 | Synermed Total Bilirubin Reagent KitCIG · Traditional | 08/07/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | 06/26/1997SE |
| K962479 | Synermed Ise ReagentsCGZ · Traditional | 03/03/1997SE |
| K963939 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | 12/18/1996SE |
| K960793 | Synermed Enzymatic CO2 Reagent KitKHS · Traditional | 03/11/1996SE |
| K953395 | Synermed Calcium Reagent KitCJY · Traditional | 08/31/1995SE |
| K952179 | Synermed Ise ReagentsJGS · Traditional | 06/20/1995SE |
| K943924 | Creatinine-Po Reagent KitCGX · Traditional | 09/20/1994SE |
| K941091 | Synermed Amylase Reagent KitJFJ · Traditional | 05/03/1994SE |
Questions and answers
When was Synermed Ir 500 Chemistry Analyzer cleared by the FDA?
Synermed Ir 500 Chemistry Analyzer (K935662) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 151 days after the submission was received.
What is the product code of K935662?
The FDA product code is JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.