FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K Number: K974810
·
Decision Feb 5, 1998
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
12
Review Days
44
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
- ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
- K Number
- K974810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Biomedica, Inc.
- Date Received
- December 23, 1997
- Decision Date
- February 5, 1998
- 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 Boston Biomedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | Nov 24, 2003 | Substantially Equivalent |
| K980351 | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT | Mar 5, 1999 | Substantially Equivalent |
| K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL | Feb 10, 1998 | Substantially Equivalent |
| K974809 | ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL | Feb 5, 1998 | Substantially Equivalent |
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Dec 11, 1997 | Substantially Equivalent |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | Oct 8, 1997 | Substantially Equivalent |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Aug 22, 1997 | Substantially Equivalent |
| K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL | Aug 12, 1997 | Substantially Equivalent |
| K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | Aug 12, 1997 | Substantially Equivalent |
| K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | Aug 7, 1997 | Substantially Equivalent |