FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNICON RA-1000 SYS IRON FOR SERUM
K Number: K843255
·
Decision Sep 14, 1984
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
66
Applicant Total
157
Review Days
25
Basic Information
- Device Name
- TECHNICON RA-1000 SYS IRON FOR SERUM
- K Number
- K843255
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- TECHNICON INSTRUMENTS CORP.
- Date Received
- August 20, 1984
- Decision Date
- September 14, 1984
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Sep 25, 1991 | Substantially Equivalent |
| K912413 | CHEM-LINK DATA BASE MANAGER | Jul 1, 1991 | Substantially Equivalent |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | Sep 27, 1990 | Substantially Equivalent |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Sep 27, 1990 | Substantially Equivalent |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | Sep 27, 1990 | Substantially Equivalent |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | Aug 29, 1990 | Substantially Equivalent |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Jul 17, 1990 | Substantially Equivalent |