ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL— 510(k) K974811
Substantially EquivalentBoston Biomedica, Inc.
FDA 510(k) clearance K974811 for ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL, Substantially Equivalent on 1998-02-10. Applicant: Boston Biomedica, Inc.. Device class: 1.
Clearance details
- Applicant
- Boston Biomedica, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Bridgewater, MA, US
Recent devices under product code JJX
view allMore clearances from Boston Biomedica, Inc.
view all- K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
- K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
- K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
- K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.