FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
K Number: K050652
·
Decision Apr 6, 2005
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
18
Review Days
23
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Basic Information
- Device Name
- SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
- K Number
- K050652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arkray, Inc.
- Date Received
- March 14, 2005
- Decision Date
- April 6, 2005
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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