FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K Number: K980351
·
Decision Mar 5, 1999
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
12
Review Days
400
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Basic Information
- Device Name
- BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- K Number
- K980351
- 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
- January 29, 1998
- Decision Date
- March 5, 1999
- 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 |
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Other Clearances by Boston Biomedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | Nov 24, 2003 | 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 |
| K974810 | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM 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 |