FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATININE - A.A.S.
K Number: K841377
·
Decision May 11, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
1
Review Days
38
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Basic Information
- Device Name
- CREATININE - A.A.S.
- K Number
- K841377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advanced Analytical Systems, Inc.
- Date Received
- April 3, 1984
- Decision Date
- May 11, 1984
- 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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