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510(k) K881649

MODIFIED PARACON(TM) CONCENTRATION KIT by Para Scientific Co. — Product Code LKS

K881649 is an FDA 510(k) premarket notification submitted by Para Scientific Co. for the device "MODIFIED PARACON(TM) CONCENTRATION KIT". The FDA issued a decision of Substantially Equivalent on April 21, 1988. 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
April 21, 1988
Date Received
April 15, 1988
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)
  • 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)
  • 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)
  • K860034 — PARA-PAK MACRO-CON (February 21, 1986)
  • K853715 — PARA CON TM (October 2, 1985)

FDA data resources