FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SYNERMED IR 500 CHEMISTRY ANALYZER
K Number: K935662
·
Decision Apr 26, 1994
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
12
Applicant Total
45
Review Days
151
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Basic Information
- Device Name
- SYNERMED IR 500 CHEMISTRY ANALYZER
- K Number
- K935662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synermed, Inc.
- Date Received
- November 26, 1993
- Decision Date
- April 26, 1994
- Product Code
- JIQ
- 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 |
|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIQ), ordered by most recent decision date.
TOTAL PROTEIN URINE/CSF GEN.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUSAM TOTAL ALBUMIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEMOCHEK URINE COLLECTION KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Jun 26, 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 |