Boston Biomedica, Inc.
West Bridgewater, MA, US
Boston Biomedica, Inc. appears in FDA device records in West Bridgewater, MA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Boston Biomedica, Inc. between 1997 and 2003. The busiest year on record is 1997, with 7. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 7 |
| 1998 | 3 |
| 1999 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | LSR | Substantially Equivalent | |
| K980351 | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT | LSR | Substantially Equivalent | |
| K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL | JJX | Substantially Equivalent | |
| K974810 | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL | LSR | Substantially Equivalent | |
| K974809 | ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL | LSR | Substantially Equivalent | |
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | LJK | Substantially Equivalent | |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | MJX | Substantially Equivalent | |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | LKQ | Substantially Equivalent | |
| K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | JJY | Substantially Equivalent | |
| K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL | JJY | Substantially Equivalent | |
| K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | JJY | Substantially Equivalent | |
| K971406 | ACCURUN 120 HAV IGG POSITIVE CONTROL | JJY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain