FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RA-1000 SYS-T4(THYROXINE)SERUM ANAL
K Number: K834102
·
Decision Mar 15, 1984
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
157
Review Days
107
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Basic Information
- Device Name
- RA-1000 SYS-T4(THYROXINE)SERUM ANAL
- K Number
- K834102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- November 29, 1983
- Decision Date
- March 15, 1984
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K912413 | CHEM-LINK DATA BASE MANAGER | Jul 1, 1991 | Substantially Equivalent |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | Sep 27, 1990 | Substantially Equivalent |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Sep 27, 1990 | Substantially Equivalent |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | Sep 27, 1990 | Substantially Equivalent |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | Aug 29, 1990 | Substantially Equivalent |
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