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510(k) K921556

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM by Medical Diagnostic Technologies, Inc. — Product Code LJZ

K921556 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 29, 1992. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1992
Date Received
April 1, 1992
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 Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 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)
  • 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)
  • K904501 — MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (February 26, 1991)
  • K895276 — DIATECH IGM-MP TEST (December 18, 1989)

FDA data resources