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510(k) K840503

SDL LISTERIA MONOCYTOGENES CONTROL by Scientific Device Laboratory, Inc. — Product Code GSI

K840503 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "SDL LISTERIA MONOCYTOGENES CONTROL". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code GSI (Antigens, Slide And Tube, All Types, Listeria Monocytogenes), a Class I device regulated under 21 CFR 866.3355. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
February 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Slide And Tube, All Types, Listeria Monocytogenes
Device Class
Class I
Regulation Number
866.3355
Review Panel
MI
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • 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)

FDA data resources