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510(k) K940251

MITOCHONDRIA EIA TEST KIT by David A. Fuccillo, Ph.D. — Product Code DBM

K940251 is an FDA 510(k) premarket notification submitted by David A. Fuccillo, Ph.D. for the device "MITOCHONDRIA EIA TEST KIT". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. David A. Fuccillo, Ph.D. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by David A. Fuccillo, Ph.D.

  • K935413 — ENA EIA TEST KIT (June 2, 1994)
  • K935418 — SCL-70 EIA TEST KIT (May 5, 1994)
  • K935417 — JO-1 EIA TEST KIT (May 5, 1994)
  • K935419 — LA EIA TEST KIT (May 5, 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)
  • K935414 — SM EIA TEST KIT (May 2, 1994)

Other clearances for product code DBM

  • K181556 — EliA M2 Immunoassay (July 13, 2018)
  • K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT (September 5, 2017)
  • K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti (August 8, 2017)
  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG) (September 2, 2010)
  • K052262 — QUANTA LITE M2 EP (MIT3) ELISA (October 27, 2005)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K030238 — BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (March 24, 2003)
  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K971909 — VIRGO AMA ELISA KIT (June 20, 1997)

FDA data resources