Company ยท US
Boston Biomedica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2003. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 24, 2003 | K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG Boston Biomedica, Inc. | LSR |
| Mar 5, 1999 | K980351 | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT Boston Biomedica, Inc. | LSR |
| Feb 10, 1998 | K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL Boston Biomedica, Inc. | JJX |
| Feb 5, 1998 | K974810 | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL Boston Biomedica, Inc. | LSR |
| Feb 5, 1998 | K974809 | ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL Boston Biomedica, Inc. | LSR |
| Dec 11, 1997 | K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL Boston Biomedica, Inc. | LJK |
| Oct 8, 1997 | K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL Boston Biomedica, Inc. | MJX |
| Aug 22, 1997 | K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL Boston Biomedica, Inc. | LKQ |
| Aug 12, 1997 | K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 12, 1997 | K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 7, 1997 | K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 7, 1997 | K971406 | ACCURUN 120 HAV IGG POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||