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510(k) K800821

AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY by Calbiochem-Behring Corp. — Product Code DBM

K800821 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
April 11, 1980
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 Calbiochem-Behring Corp.

  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY (April 27, 1983)
  • K830214 — AFT SYSTEM III (March 9, 1983)
  • K820812 — CREATINE KINASE-MB KIT (April 12, 1982)
  • K813493 — ENZYGNOST TM RUBELLA IGM (March 4, 1982)
  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
  • K812458 — PADAC (September 23, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810404 — RHEUMATOID FACTORS REFERENCE SERUM (March 11, 1981)

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