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510(k) K984479

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 by Bio-Rad — Product Code LKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
December 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Bio-Rad

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  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code LKP

  • K202067 — EliA SmDP-S (July 14, 2021)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)