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510(k) K831334

TISSUE CASSETTES FOR PROCESSING-EM BED by Surgipath Medical Industries, Inc. — Product Code IDZ

K831334 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "TISSUE CASSETTES FOR PROCESSING-EM BED". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code IDZ (Cassettes, Tissue), a Class I device regulated under 21 CFR 864.3010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
April 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassettes, Tissue
Device Class
Class I
Regulation Number
864.3010
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)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 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)

Other clearances for product code IDZ

  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K862457 — LYNX EL MICROSCOPY TISSUE PROCESSOR (July 16, 1986)
  • K833857 — MACLEAN-FOGG, TISSUE CASSETTES (December 2, 1983)
  • K760623 — LANCER PARAPLAST HISTO PROCESS CASSETTE (September 27, 1976)

FDA data resources