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510(k) K924893

MICROSPORIDIUM CONTROL SLIDE by Scientific Device Laboratory, Inc. — Product Code LJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
September 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Quality Control Slides
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K895848 — PRESSURE STEAM STERILIZERS (December 11, 1989)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K884011 — SNAP N' STAIN IRON STAIN (October 6, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K881598 — SDL TRICHROME STAIN (May 4, 1988)
  • K840506 — HAEMOPHILUS INFLUENZAE TYPE B (April 4, 1984)

Other clearances for product code LJG

  • K943228 — MICROSPORIDIUM CONTROL SET (October 27, 1994)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883569 — HISTO-CHECK GRAM NEGATIVE SLIDES (October 6, 1988)
  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883208 — HISTO-CHECK SLIDES (August 25, 1988)