FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDAS ROTAVIRUS ASSAY
K Number: K965092
·
Decision May 5, 1997
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
49
Review Days
137
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Basic Information
- Device Name
- VIDAS ROTAVIRUS ASSAY
- K Number
- K965092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- December 19, 1996
- Decision Date
- May 5, 1997
- Product Code
- LIQ
- 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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | FDA class 1 | Microbiology |
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Other Clearances by Biomerieux Vitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |
| K942049 | BIOMERIEUX HEMOLAB COFAC II | May 19, 1995 | Substantially Equivalent |