510(k) K974261

ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code LJK

K974261 is an FDA 510(k) premarket notification submitted by Boston Biomedica, Inc. for the device "ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on December 11, 1997. The device falls under product code LJK (Antisera, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Boston Biomedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 11, 1997
Date Received: November 13, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antisera, If, Toxoplasma Gondii
Device Class: Class II
Regulation Number: 866.3780
Review Panel: MI
Submission Type

Other clearances by Boston Biomedica, Inc.

K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (November 24, 2003)
K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT (March 5, 1999)
K974811 — ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (February 10, 1998)
K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (February 5, 1998)
K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (February 5, 1998)
K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
K971657 — ACCURUN 121 HAV IGM POSITIVE CONTROL (August 12, 1997)
K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL (August 12, 1997)
K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL (August 7, 1997)

510(k) K974261

Clearance Details

Device Classification

Other clearances by Boston Biomedica, Inc.

Other clearances for product code LJK

FDA data resources