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510(k) K935414

SM EIA TEST KIT by David A. Fuccillo, Ph.D. — Product Code LJM

K935414 is an FDA 510(k) premarket notification submitted by David A. Fuccillo, Ph.D. for the device "SM EIA TEST KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1994. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. David A. Fuccillo, Ph.D. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1994
Date Received
November 9, 1993
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 David A. Fuccillo, Ph.D.

  • K935413 — ENA EIA TEST KIT (June 2, 1994)
  • K935417 — JO-1 EIA TEST KIT (May 5, 1994)
  • K935418 — SCL-70 EIA TEST KIT (May 5, 1994)
  • K935419 — LA EIA TEST KIT (May 5, 1994)
  • K940251 — MITOCHONDRIA EIA TEST KIT (May 3, 1994)
  • K935415 — RNP EIA TEST KIT (May 2, 1994)
  • K935416 — RO EIA TEST KIT (May 2, 1994)
  • K940253 — HISTONE EIA TEST KIT (May 2, 1994)

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