FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K Number: K112955
·
Decision Jan 5, 2012
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
26
Applicant Total
40
Review Days
93
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Basic Information
- Device Name
- NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
- K Number
- K112955
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1450
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nova Biomedical Corporation
- Date Received
- October 4, 2011
- Decision Date
- January 5, 2012
- Product Code
- KHP
- 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 |
|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | FDA class 1 | Clinical Chemistry |
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