FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANBIO Y-GT (LIQUICOLOR) TEST SET
K Number: K941315
·
Decision Jul 14, 1994
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
51
Applicant Total
47
Review Days
118
Basic Information
- Device Name
- STANBIO Y-GT (LIQUICOLOR) TEST SET
- K Number
- K941315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- STANBIO LABORATORY
- Date Received
- March 18, 1994
- Decision Date
- July 14, 1994
- Product Code
- JQB
- 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 |
|---|---|---|---|
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
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Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
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| K Number | Device Name | ||
|---|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Jun 10, 2009 | Substantially Equivalent |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Jul 18, 2008 | Substantially Equivalent |
| K050283 | CREATININE LIQUICOLOR | Jun 30, 2005 | Substantially Equivalent |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Jun 30, 2005 | Substantially Equivalent |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Mar 14, 2005 | Substantially Equivalent |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Oct 14, 2004 | Substantially Equivalent |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | Mar 12, 2004 | Substantially Equivalent |
| 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 |