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510(k) K940251

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

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)
  • K935414 — SM EIA TEST KIT (May 2, 1994)
  • K935416 — RO EIA TEST KIT (May 2, 1994)
  • K940253 — HISTONE EIA TEST KIT (May 2, 1994)
  • K935415 — RNP EIA TEST KIT (May 2, 1994)

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  • 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)