FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIM HISENSE TEST KIT
K Number: K952215
·
Decision Aug 9, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
116
Applicant Total
27
Review Days
90
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Basic Information
- Device Name
- SERIM HISENSE TEST KIT
- K Number
- K952215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serim Research Corp.
- Date Received
- May 11, 1995
- Decision Date
- August 9, 1995
- Product Code
- FIP
- 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 |
|---|---|---|---|
| FIP | Subsystem, Water Purification | FDA class 2 | Gastroenterology, Urology |
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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 |
| K043031 | SERIM DIALYSATE MONITOR TEST STRIP | Jun 13, 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 |