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510(k) K920616

DIASTAT ANTI-HISTONE KIT by Shield Diagnostics, Ltd. — Product Code LJM

K920616 is an FDA 510(k) premarket notification submitted by Shield Diagnostics, Ltd. for the device "DIASTAT ANTI-HISTONE KIT". The FDA issued a decision of Substantially Equivalent on July 14, 1992. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1992
Date Received
February 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Shield Diagnostics, Ltd.

  • K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (April 17, 2000)
  • K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (October 15, 1998)
  • K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (August 21, 1998)
  • K972981 — SHIELD HELICO-G2 ELISA KIT (March 17, 1998)
  • K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (November 15, 1996)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K955303 — DIASTAT ANTI-CARDIOLIPIN KIT (May 30, 1996)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)
  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)

Other clearances for product code LJM

  • K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (November 27, 2018)
  • K151559 — ImmuLisa Enhanced Centromere Antibody ELISA (March 11, 2016)
  • K140493 — ELIA SCL-70S IMMUNOASSAY (October 30, 2014)
  • K123880 — QUANTA FLASH CENTROMERE (February 7, 2014)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)
  • K131185 — ANA SCREEN ELISA (IGG) (July 15, 2013)
  • K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (March 13, 2009)
  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)

FDA data resources