FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K Number: K941313
·
Decision May 17, 1994
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
47
Review Days
60
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Basic Information
- Device Name
- STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
- K Number
- K941313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stanbio Laboratory
- Date Received
- March 18, 1994
- Decision Date
- May 17, 1994
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | Mar 10, 2004 | Substantially Equivalent |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Oct 24, 2003 | Substantially Equivalent |
| K020378 | QUPID PLUS E.R. | Jun 21, 2002 | Substantially Equivalent |