Home / 510(k) Clearances / K053257

510(k) K053257

PARA-PRO FC50 by Alpha-Tec Systems, Inc. — Product Code LKS

K053257 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "PARA-PRO FC50". The FDA issued a decision of Substantially Equivalent on May 12, 2006. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2006
Date Received
November 22, 2005
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 Alpha-Tec Systems, Inc.

  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K890148 — ATS TB RAPID STAIN SET PRODUCT #034-45 (January 24, 1989)
  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)
  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID (August 4, 1988)
  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K880989 — ATS CRYPTOSPORIDIUM STAIN SET (May 13, 1988)

Other clearances for product code LKS

  • 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)
  • 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