ACCURUN 140 RUBELLA IGG POSITIVE CONTROL— 510(k) K972986
Substantially EquivalentBoston Biomedica, Inc.
FDA 510(k) clearance K972986 for ACCURUN 140 RUBELLA IGG POSITIVE CONTROL, Substantially Equivalent on 1997-10-08. Applicant: Boston Biomedica, Inc.. Device class: 1.
Clearance details
- Applicant
- Boston Biomedica, Inc.
- Product code
- Code MJX
- 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 MJX
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
- K974811 — ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
- K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
- K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.