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510(k) K944867

TOXOSTAT by Bio-Whittaker, Inc., A Cambrex Co. — Product Code LGD

K944867 is an FDA 510(k) premarket notification submitted by Bio-Whittaker, Inc., A Cambrex Co. for the device "TOXOSTAT". The FDA issued a decision of Substantially Equivalent on May 14, 1996. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Bio-Whittaker, Inc., A Cambrex Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
September 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Bio-Whittaker, Inc., A Cambrex Co.

  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (September 17, 1997)
  • K950227 — RUBELISA (RUBESTAT) (August 15, 1995)

Other clearances for product code LGD

  • K242022 — Access Toxo IgG (March 28, 2025)
  • K242095 — Access Toxo IgM II (October 11, 2024)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K210596 — ARCHITECT Toxo IgG (May 19, 2022)
  • K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (June 23, 2017)
  • K142826 — ADVIA Centaur Toxoplasma M (Toxo M) (December 22, 2015)
  • K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (August 28, 2013)
  • K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (August 9, 2013)
  • K101946 — VIDAS TOXO IGG AVIDITY (May 18, 2011)
  • K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (May 4, 2011)

FDA data resources