Home / 510(k) Clearances / K770592

510(k) K770592

CYTOLOGY FIXATIVE by Surgipath Medical Industries, Inc. — Product Code LEA

K770592 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "CYTOLOGY FIXATIVE". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code LEA (Preservative, Cytological), a Class I device regulated under 21 CFR 864.4010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1977
Date Received
March 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preservative, Cytological
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)
  • 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)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)

Other clearances for product code LEA

  • K873594 — TIF FECAL TEST (September 29, 1987)
  • K761000 — PAP-TRAY I (CATALOG #C600-1) (December 6, 1976)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)

FDA data resources