Home / 510(k) Clearances / K971657

510(k) K971657

ACCURUN 121 HAV IGM POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code JJY

K971657 is an FDA 510(k) premarket notification submitted by Boston Biomedica, Inc. for the device "ACCURUN 121 HAV IGM POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on August 12, 1997. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Boston Biomedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1997
Date Received
May 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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)
  • K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (February 5, 1998)
  • K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (February 5, 1998)
  • K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (December 11, 1997)
  • K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL (August 12, 1997)
  • K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL (August 7, 1997)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources