Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Boston Biomedica, Inc. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

58 daysmedian FDA review time
113 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGGBoston Biomedica, Inc.2003-11-24830
K980351BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERNBoston Biomedica, Inc.1999-03-054000
K974811ACCURUN(TM) 150 HSV IGG POSITIVE CONTROLBoston Biomedica, Inc.1998-02-10490
K974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLBoston Biomedica, Inc.1998-02-05440
K974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLBoston Biomedica, Inc.1998-02-05440
K974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLBoston Biomedica, Inc.1997-12-11280
K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.1997-10-08580
K972884ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.1997-08-22170
K971657ACCURUN 121 HAV IGM POSITIVE CONTROLBoston Biomedica, Inc.1997-08-12980
K972048ACCURUN 117 HBEAG POSITIVE CONTROLBoston Biomedica, Inc.1997-08-12710
K971406ACCURUN 120 HAV IGG POSITIVE CONTROLBoston Biomedica, Inc.1997-08-071130
K972307ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CBoston Biomedica, Inc.1997-08-07490

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda