Home / 510(k) Clearances / K862725

510(k) K862725

SACCOMANNO SPECIMAN SOLUTION by Mill-Rose Laboratory — Product Code LDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixative, Alcohol Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Mill-Rose Laboratory

  • K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDUR (October 30, 1998)
  • K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOL (October 30, 1998)
  • K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (May 23, 1997)
  • K962736 — MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (July 29, 1996)
  • K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH (April 29, 1996)
  • K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (December 22, 1995)
  • K951600 — MILL-ROSE ROTATABLE POLYPECTOMY SNARE (December 18, 1995)
  • K954745 — MILL-ROSE RIGID SCOPE CLEANING BRUSHES (November 27, 1995)
  • K951051 — RITE-BITE BIOPSY FORCEPS (March 24, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)

Other clearances for product code LDZ

  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K843428 — BIOFIX (September 27, 1984)
  • K842913 — WRIGHT STAIN FIXATIVE (September 7, 1984)
  • K831061 — PVA FIXATIVE/FORMALIN (June 8, 1983)
  • K761138 — FA TISSUE FIXATIVE & WASH SET (January 6, 1978)