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510(k) K823804

MYCOPLASMELISA TEST KIT by M.A. Bioproducts — Product Code LJZ

K823804 is an FDA 510(k) premarket notification submitted by M.A. Bioproducts for the device "MYCOPLASMELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. M.A. Bioproducts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
December 17, 1982
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 M.A. Bioproducts

  • K822883 — HERPELISA KIT (July 26, 1983)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)
  • K830615 — CYTOMEGELISA STAT (May 9, 1983)
  • K823805 — VARICELISA TEST KIT (May 5, 1983)
  • K821967 — CHLAMYDELISA TEST KIT (August 3, 1982)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)
  • K813221 — TOXOELISA TEST KIT (January 26, 1982)
  • K812531 — CELL CULTURE REAGENTS (October 23, 1981)
  • K812123 — CYTOMEGELISA TEST KIT (September 23, 1981)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)

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)
  • K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (May 5, 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)

FDA data resources