FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SYNERMED IR 200 CHEMISTRY ANALYZER
K Number: K971491
·
Decision Jun 26, 1997
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
45
Review Days
63
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Basic Information
- Device Name
- SYNERMED IR 200 CHEMISTRY ANALYZER
- K Number
- K971491
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synermed, Inc.
- Date Received
- April 24, 1997
- Decision Date
- June 26, 1997
- Product Code
- JJF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Synermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Sep 25, 1997 | Substantially Equivalent |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Aug 7, 1997 | Substantially Equivalent |
| K962479 | SYNERMED ISE REAGENTS | Mar 3, 1997 | Substantially Equivalent |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Dec 18, 1996 | Substantially Equivalent |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Mar 11, 1996 | Substantially Equivalent |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Aug 31, 1995 | Substantially Equivalent |
| K952179 | SYNERMED ISE REAGENTS | Jun 20, 1995 | Substantially Equivalent |
| K943924 | CREATININE-PO REAGENT KIT | Sep 20, 1994 | Substantially Equivalent |
| K941091 | SYNERMED AMYLASE REAGENT KIT | May 3, 1994 | Substantially Equivalent |
| K941400 | SYNERMED ISE REAGENTS | Apr 26, 1994 | Substantially Equivalent |