FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K Number: K972986
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
12
Review Days
58
Basic Information
- Device Name
- ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- K Number
- K972986
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BOSTON BIOMEDICA, INC.
- Date Received
- August 11, 1997
- Decision Date
- October 8, 1997
- Product Code
- MJX
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MJX | Kit, Serological, Positive Control | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |
| 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 |
| 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 |
| K971406 | ACCURUN 120 HAV IGG POSITIVE CONTROL | Aug 7, 1997 | Substantially Equivalent |