FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS CMV IGG ASSAY
K Number: K920661
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
39
Review Days
365
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Basic Information
- Device Name
- VIDAS CMV IGG ASSAY
- K Number
- K920661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitek Systems, Inc.
- Date Received
- February 13, 1992
- Decision Date
- February 12, 1993
- Product Code
- LFZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | FDA class 2 | Microbiology |
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ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
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·Microbiology
Other Clearances by Vitek Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Jun 24, 1991 | Substantially Equivalent |