Boston Biomedica, Inc.: FDA clearances and approvals
Boston Biomedica, Inc. has 12 FDA 510(k) clearances (first 1997, latest 2003), across 6 product codes in 2 review panels. Median 510(k) review time: 54 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LJK | Antisera, If, Toxoplasma Gondii | 1 | 1 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 1 | 1 |
| MJX | Kit, Serological, Positive Control | 1 | 1 |
Review panels
- Microbiology (7)
- Clinical Chemistry (5)
Most recent Boston Biomedica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032713 | BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG | LSR | 2003-11-24 | 83 |
| K980351 | BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT | LSR | 1999-03-05 | 400 |
| K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL | JJX | 1998-02-10 | 49 |
| K974810 | ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL | LSR | 1998-02-05 | 44 |
| K974809 | ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL | LSR | 1998-02-05 | 44 |
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | LJK | 1997-12-11 | 28 |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | MJX | 1997-10-08 | 58 |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | LKQ | 1997-08-22 | 17 |
| K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | JJY | 1997-08-12 | 71 |
| K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL | JJY | 1997-08-12 | 98 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Boston Biomedica, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Boston Biomedica, Inc. have?
Boston Biomedica, Inc. has 12 FDA 510(k) clearances (first 1997, latest 2003), across 6 product codes in 2 review panels.
How long does FDA take to clear Boston Biomedica, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Boston Biomedica, Inc.'s cleared 510(k)s is 54 days.
What devices does Boston Biomedica, Inc. make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); LSR (Reagent, Borrelia Serological Reagent, 4); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1).
Has Boston Biomedica, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Boston Biomedica, Inc. Related entities may recall under other names.
Next steps
- See all 12 Boston Biomedica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Boston Biomedica, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.