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510(k) K963054

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) by Genbio — Product Code LJZ

K963054 is an FDA 510(k) premarket notification submitted by Genbio for the device "IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)". The FDA issued a decision of Substantially Equivalent on May 5, 1997. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Genbio has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
August 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
Review Panel
MI
Submission Type

Other clearances by Genbio

  • K010301 — IMMUNOWELL EA (D) IGG TEST (June 11, 2001)
  • K974244 — IMMUNODOT MONO-M TEST (September 22, 1998)
  • K974226 — IMMUNODOT MONO-G TEST (September 22, 1998)
  • K973939 — IMMUNOWELL VCA IGM TEST (August 10, 1998)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K973940 — IMMUNOWELL EBV VCA IGG TEST (August 10, 1998)
  • K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (May 2, 1997)
  • K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST (May 3, 1996)
  • K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST (May 3, 1996)

Other clearances for product code LJZ

  • K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (January 11, 1999)
  • K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM (August 20, 1997)
  • K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM (July 14, 1997)
  • K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM (June 16, 1997)
  • K963055 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (May 2, 1997)
  • K934550 — IMMUNOCARD MYCOPLASMA (September 20, 1994)
  • K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (August 20, 1992)
  • K921556 — MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (June 29, 1992)
  • K904501 — MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (February 26, 1991)
  • K895276 — DIATECH IGM-MP TEST (December 18, 1989)

FDA data resources