Home / 510(k) Clearances / K031308

510(k) K031308

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 by Rhigene, Inc. — Product Code DBM

K031308 is an FDA 510(k) premarket notification submitted by Rhigene, Inc. for the device "RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760". The FDA issued a decision of Substantially Equivalent on September 26, 2003. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Rhigene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2003
Date Received
April 24, 2003
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 Rhigene, Inc.

  • K040711 — MESACUP TEST PR-3 (April 2, 2004)
  • K040586 — MESACUP TEST MPO, MODEL 11053 (March 22, 2004)
  • K040200 — MESACUP-2 TEST CENP-B (March 4, 2004)
  • K033528 — MESACUP-2 TEST JO-1, MODEL 10756 (December 22, 2003)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (July 5, 2002)
  • K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (April 11, 2002)
  • K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (June 9, 2000)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000752 — RHIGENE MESACUP2 TEST- RNP (May 9, 2000)

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)
  • 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)
  • K962452 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (November 25, 1996)

FDA data resources