FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
K Number: K032936
·
Decision Mar 12, 2004
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
47
Review Days
172
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
- K Number
- K032936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stanbio Laboratory
- Date Received
- September 22, 2003
- Decision Date
- March 12, 2004
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIX), ordered by most recent decision date.
VITROS Chemistry Products Calibrator Kit 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSTEM CALIBRATER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Stanbio Laboratory
| 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 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Jun 30, 2005 | Substantially Equivalent |
| K050283 | CREATININE 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 |
| 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 |
| K974429 | RAPET CRP | Feb 18, 1998 | Substantially Equivalent |