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510(k) K853715

PARA CON TM by Para Scientific Co. — Product Code LKS

K853715 is an FDA 510(k) premarket notification submitted by Para Scientific Co. for the device "PARA CON TM". The FDA issued a decision of Substantially Equivalent on October 2, 1985. 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
October 2, 1985
Date Received
September 4, 1985
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.

  • K021420 — PARACON II/FECAL CONCENTRATOR II (June 4, 2002)
  • 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)

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)
  • 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)

FDA data resources