FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOTECHNICON V TISSUE PROCESS SYS
K Number: K834599
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
11
Applicant Total
157
Review Days
36
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Basic Information
- Device Name
- AUTOTECHNICON V TISSUE PROCESS SYS
- K Number
- K834599
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3875
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- December 30, 1983
- Decision Date
- February 4, 1984
- Product Code
- IEO
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IEO | Processor, Tissue, Automated | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IEO), ordered by most recent decision date.
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SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
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LX 300 TISSUE PROCESSOR
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LX120 TISSUE PROCESSOR
FDA 510(k)
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LKB 2189 ULTROPROCESSOR
FDA 510(k)
FDA Class 1
·Pathology
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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 |
| 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 |