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510(k) K021420

PARACON II/FECAL CONCENTRATOR II by Para Scientific Co. — Product Code LKS

K021420 is an FDA 510(k) premarket notification submitted by Para Scientific Co. for the device "PARACON II/FECAL CONCENTRATOR II". The FDA issued a decision of Substantially Equivalent on June 4, 2002. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900. Para Scientific Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2002
Date Received
May 3, 2002
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 Para Scientific Co.

  • K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - (November 27, 1996)
  • K881649 — MODIFIED PARACON(TM) CONCENTRATION KIT (April 21, 1988)
  • K872751 — FLUORTRAN - C(TM) (July 23, 1987)
  • K853715 — PARA CON TM (October 2, 1985)

Other clearances for product code LKS

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K941110 — PARAKIT (May 17, 1994)
  • K941129 — CON-KIT (May 9, 1994)
  • K935316 — PARASAFE(R) FIXATIVE (February 17, 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