FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT PROFILE M ANALYZER
K Number: K981427
·
Decision May 12, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
89
Review Days
26
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Basic Information
- Device Name
- STAT PROFILE M ANALYZER
- K Number
- K981427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nova Biomedical Corp.
- Date Received
- April 16, 1998
- Decision Date
- May 12, 1998
- Product Code
- GKF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKF | Instrument, Hematocrit, Automated | FDA class 2 | Hematology |
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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 |
| 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 |