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510(k) K970150

MYCOPLASMA IGG ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code LJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
January 15, 1997
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

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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)
  • 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)
  • K895276 — DIATECH IGM-MP TEST (December 18, 1989)