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510(k) K941129

CON-KIT by Medical Chemical Corp. — Product Code LKS

K941129 is an FDA 510(k) premarket notification submitted by Medical Chemical Corp. for the device "CON-KIT". The FDA issued a decision of Substantially Equivalent on May 9, 1994. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1994
Date Received
March 9, 1994
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 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)
  • K933370 — STOOL TRANSPORT/PROCESSOR (February 17, 1994)
  • K935316 — PARASAFE(R) FIXATIVE (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