FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNICON SMAC 3 SYSTEM
K Number: K875105
·
Decision Feb 16, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
157
Review Days
64
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Basic Information
- Device Name
- TECHNICON SMAC 3 SYSTEM
- K Number
- K875105
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- December 14, 1987
- Decision Date
- February 16, 1988
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Technicon Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | Nov 27, 1991 | Substantially Equivalent |
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | Nov 27, 1991 | Substantially Equivalent |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | Nov 22, 1991 | Substantially Equivalent |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Sep 25, 1991 | Substantially Equivalent |
| 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 |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Jul 17, 1990 | Substantially Equivalent |