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510(k) K980077

PARA-PAK SPINCON by Meridian Diagnostics, Inc. — Product Code LKS

K980077 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PARA-PAK SPINCON". The FDA issued a decision of Substantially Equivalent on April 2, 1998. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1998
Date Received
January 8, 1998
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 Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)
  • K961508 — IMMUNOCARD H. PYLORI (January 21, 1997)

Other clearances for product code LKS

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K021420 — PARACON II/FECAL CONCENTRATOR II (June 4, 2002)
  • 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