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510(k) K873594

TIF FECAL TEST by Devetec, Inc. — Product Code LEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1987
Date Received
September 4, 1987
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 Devetec, Inc.

  • K894045 — MODIFIED POLYCHROME IV STAIN (July 25, 1989)
  • K870988 — PRICE'S ACID-FAST STAIN (March 30, 1987)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)

Other clearances for product code LEA

  • K770592 — CYTOLOGY FIXATIVE (May 20, 1977)
  • K761000 — PAP-TRAY I (CATALOG #C600-1) (December 6, 1976)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)