FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATINE LIQUID STABLE REAGENT SET
K Number: K851849
·
Decision May 20, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
156
Applicant Total
107
Review Days
24
Basic Information
- Device Name
- CREATINE LIQUID STABLE REAGENT SET
- K Number
- K851849
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL ANALYSIS SYSTEMS, INC.
- Date Received
- April 26, 1985
- Decision Date
- May 20, 1985
- 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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