FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANBIO ACETAMINOPHEN TEST SET #0850
K Number: K801014
·
Decision Jun 20, 1980
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
47
Review Days
53
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Basic Information
- Device Name
- STANBIO ACETAMINOPHEN TEST SET #0850
- K Number
- K801014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- April 28, 1980
- Decision Date
- June 20, 1980
- Product Code
- LDP
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDP), ordered by most recent decision date.
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ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
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ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
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DIMENSION VISTA FLEX REAGENT CARTRIDGES
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| 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 |