FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K Number: K081719
·
Decision Jul 18, 2008
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
47
Review Days
30
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Basic Information
- Device Name
- STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
- K Number
- K081719
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stanbio Laboratory
- Date Received
- June 18, 2008
- Decision Date
- July 18, 2008
- Product Code
- GKR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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Other Clearances by Stanbio Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Jun 10, 2009 | 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 |
| 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 |
| K974429 | RAPET CRP | Feb 18, 1998 | Substantially Equivalent |