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510(k) K881922

CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE by Surgipath Medical Industries, Inc. — Product Code LDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1988
Date Received
May 9, 1988
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 Surgipath Medical Industries, Inc.

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K881921 — C-E BRUSH (July 19, 1988)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 1986)
  • K863548 — ROTARY MICROTOME (September 19, 1986)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)

Other clearances for product code LDZ

  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K862725 — SACCOMANNO SPECIMAN SOLUTION (August 1, 1986)
  • 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)