Synermed Ir 200 Chemistry Analyzer
FDA 510(k) K971491 · Synermed, Inc.
510(k) numberK971491
Submission
- Device name
- Synermed Ir 200 Chemistry Analyzer
- Applicant
- Synermed, Inc.
Quebec, Canada, CA - Received
- April 24, 1997
- Decision date
- June 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| 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 |
| K941400 | Synermed Ise ReagentsJGS · Traditional | 04/26/1994SE |
Questions and answers
When was Synermed Ir 200 Chemistry Analyzer cleared by the FDA?
Synermed Ir 200 Chemistry Analyzer (K971491) received a 510(k) decision of Substantially Equivalent on June 26, 1997, 63 days after the submission was received.
What is the product code of K971491?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.