FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS LYME SCREEN II
K Number: K943812
·
Decision Jun 13, 1995
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
49
Review Days
312
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
- VIDAS LYME SCREEN II
- K Number
- K943812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- August 5, 1994
- Decision Date
- June 13, 1995
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSR), ordered by most recent decision date.
Lyme-ID IgG Test; Bio-ID800
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgM ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgG ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
Viramed Borrela All-In-One ViraChip Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
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 |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 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 |
| K942049 | BIOMERIEUX HEMOLAB COFAC II | May 19, 1995 | Substantially Equivalent |