FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARBITURATE TEST SET #0550-050
K Number: K823237
·
Decision Nov 29, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
47
Review Days
28
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Basic Information
- Device Name
- BARBITURATE TEST SET #0550-050
- K Number
- K823237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- November 1, 1982
- Decision Date
- November 29, 1982
- Product Code
- DJN
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJN | Mercury Dithiazone, Colorimetry, Barbiturate | FDA class 2 | Clinical Toxicology |
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 |
| 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 |