FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
K Number: K042270
·
Decision Oct 6, 2004
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
88
Applicant Total
1
Review Days
44
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Basic Information
- Device Name
- STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
- K Number
- K042270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stat Chem, Inc.
- Date Received
- August 23, 2004
- Decision Date
- October 6, 2004
- Product Code
- CEM
- 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
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