FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON DPA-1 IMMUNOGLOBULIN A
K Number: K883492
·
Decision Sep 22, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
53
Applicant Total
157
Review Days
37
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Basic Information
- Device Name
- TECHNICON DPA-1 IMMUNOGLOBULIN A
- K Number
- K883492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- August 16, 1988
- Decision Date
- September 22, 1988
- Product Code
- CZP
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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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 |