FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K Number: K895808
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
157
Review Days
15
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
- K Number
- K895808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- October 2, 1989
- Decision Date
- October 17, 1989
- Product Code
- DCF
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DCF), ordered by most recent decision date.
Optilite Low Level Albumin Kit
FDA 510(k)
FDA Class 2
·Immunology
Human Microalbumin kit for use on SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
Urine/CSF Albumin, Urine/CSF Albumin Calibrator
FDA 510(k)
FDA Class 2
·Immunology
HUMAN ALBUMIN CSF KIT
FDA 510(k)
FDA Class 2
·Immunology
TINA-QUANT ALBUMIN GEN.2
FDA 510(k)
FDA Class 2
·Immunology
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
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 |