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510(k) K935316

PARASAFE(R) FIXATIVE by Scientific Device Laboratory, Inc. — Product Code LKS

K935316 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "PARASAFE(R) FIXATIVE". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
November 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Parasite Concentration
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K895848 — PRESSURE STEAM STERILIZERS (December 11, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890670 — CRYPTOSPORIDIUM 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 LKS

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K021420 — PARACON II/FECAL CONCENTRATOR II (June 4, 2002)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K941110 — PARAKIT (May 17, 1994)
  • K941129 — CON-KIT (May 9, 1994)
  • K933370 — STOOL TRANSPORT/PROCESSOR (February 17, 1994)
  • K931849 — PARAPREP (December 2, 1993)
  • K881649 — MODIFIED PARACON(TM) CONCENTRATION KIT (April 21, 1988)
  • K860034 — PARA-PAK MACRO-CON (February 21, 1986)
  • K853715 — PARA CON TM (October 2, 1985)

FDA data resources