FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K Number: K891385
·
Decision Apr 18, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
39
Review Days
40
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
- VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
- K Number
- K891385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Vitek Systems, Inc.
- Date Received
- March 9, 1989
- Decision Date
- April 18, 1989
- Product Code
- DEW
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEW), ordered by most recent decision date.
TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
SPIFE IFE CALIBRATOR AND CONTROL KIT
FDA 510(k)
FDA Class 2
·Immunology
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY IGG
FDA 510(k)
FDA Class 2
·Immunology
IGG
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Vitek Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920661 | VIDAS CMV IGG ASSAY | Feb 12, 1993 | Substantially Equivalent |
| K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Jul 28, 1992 | Substantially Equivalent |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Apr 8, 1992 | Substantially Equivalent |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | Apr 7, 1992 | Substantially Equivalent |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | Oct 11, 1991 | Substantially Equivalent |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Sep 23, 1991 | Substantially Equivalent |
| K910230 | LYME-SPOT IF KIT | Aug 30, 1991 | Substantially Equivalent |
| K910210 | SLIDEX MENINGITE-KIT 5 | Aug 12, 1991 | Substantially Equivalent |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Jul 26, 1991 | Substantially Equivalent |