FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
K Number: K101633
·
Decision Aug 27, 2010
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
89
Review Days
78
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Basic Information
- Device Name
- NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
- K Number
- K101633
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nova Biomedical Corp.
- Date Received
- June 10, 2010
- Decision Date
- August 27, 2010
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | 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 |
| 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 |
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | Apr 28, 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 |