FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K Number: K060345
·
Decision Apr 28, 2006
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
89
Review Days
77
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Basic Information
- Device Name
- NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
- K Number
- K060345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nova Biomedical Corp.
- Date Received
- February 10, 2006
- Decision Date
- April 28, 2006
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Nova Biomedical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | Aug 17, 2011 | Substantially Equivalent |
| K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH | Aug 27, 2010 | Substantially Equivalent |
| K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS | Jan 15, 2010 | Substantially Equivalent |
| K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | Jul 11, 2007 | Substantially Equivalent |
| K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | Jun 13, 2007 | Substantially Equivalent |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | May 7, 2007 | Substantially Equivalent |
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Jan 24, 2007 | Substantially Equivalent |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nov 1, 2006 | Substantially Equivalent |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | May 7, 2004 | Substantially Equivalent |
| K033433 | NOVA GLUCOSE CONTROL SOLUTIONS | Jan 2, 2004 | Substantially Equivalent |