Ats Pva Fixative Solution

510(k) Number

K881698 ↗

FDA product code

LDZ

Device class

Class I

Regulation

21 CFR Part 864.4010

Advisory committee

Pathology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LDZ (Fixative, Alcohol Containing).

• BD CytoRich™ Blue Preservative 491335 by Becton, Dickinson and Company
• Tissue-Tek Xpress® 7115 by Sakura Finetek USA, Inc
• Alinity 08P7901 by Abbott Laboratories
• Tissue-Tek Xpress® x50 7760 by Sakura Finetek USA, Inc
• FA TISSUE FIXATIVE & WASH SET by ZEUS SCIENTIFIC, INC.
• CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE by Surgipath Medical Industries, Inc.
• BIOFIX by Accra Laboratories, Inc.
• WRIGHT STAIN FIXATIVE by E K Ind., Inc.
• PVA FIXATIVE/FORMALIN by American Micro Scan
• SACCOMANNO SPECIMAN SOLUTION by Mill-Rose Laboratory

• Ats Parasitology Stain Control Slide

  Class I

  FDA 510(k) K823705 Active Cleared 7 Jan 1983

• Para-Pro FC50

  Class I

  FDA 510(k) K053257 Active Cleared 12 May 2006

• Ats Tb Rapid Stain Set Product #034-45

  Class I

  FDA 510(k) K890148 Active Cleared 24 Jan 1989

• Ats Para-Set Modified Pva Fixative Solution

  Class I

  FDA 510(k) K883048 Active Cleared 17 Aug 1988

See all devices from Alpha-Tec Systems, Inc. →