FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIM DIALYSATE MONITOR TEST STRIP
K Number: K043031
·
Decision Jun 13, 2005
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
27
Review Days
222
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Basic Information
- Device Name
- SERIM DIALYSATE MONITOR TEST STRIP
- K Number
- K043031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Serim Research Corp.
- Date Received
- November 3, 2004
- Decision Date
- June 13, 2005
- Product Code
- NTZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| NTZ | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator | FDA class 2 | Gastroenterology, Urology |
Other Clearances by Serim Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K120652 | RAPICIDE OPA-28 TEST STRIP | Oct 12, 2012 | Substantially Equivalent |
| K092346 | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 | Jan 7, 2010 | Substantially Equivalent |
| K083295 | SERIM DISINTEK GTA 2.1%, MODEL: 5164 | Mar 16, 2009 | Substantially Equivalent |
| K082352 | SERIM DISINTEK OPA TEST STRIP | Sep 25, 2008 | Substantially Equivalent |
| K081370 | SERIM DISINTEK OPA TEST STRIP | Jul 11, 2008 | Substantially Equivalent |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | May 6, 2008 | Substantially Equivalent |
| K052388 | SERIM PERACETIC ACID CHEMICAL INDICATOR | Dec 1, 2005 | Substantially Equivalent |
| K014038 | PYLORITEK VP TEST KIT 5140VP | Feb 8, 2002 | Substantially Equivalent |
| K012115 | SERIM BLOOD LEAK TEST STRIP-2 | Nov 30, 2001 | Substantially Equivalent |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | May 5, 2000 | Substantially Equivalent |