FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT PROFILE PHOX PLUS L ANALYZER
K Number: K023567
·
Decision Dec 20, 2002
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
89
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STAT PROFILE PHOX PLUS L ANALYZER
- K Number
- K023567
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nova Biomedical Corp.
- Date Received
- October 23, 2002
- Decision Date
- December 20, 2002
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHL), ordered by most recent decision date.
ABL90 FLEX PLUS System, safeCLINITUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG4+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G3+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |