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510(k) K922580

BARTELS CYTOMEGALOVIRUS IGM EIA by Baxter Diagnostics, Inc. — Product Code LKQ

K922580 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "BARTELS CYTOMEGALOVIRUS IGM EIA". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
May 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Baxter Diagnostics, Inc.

  • K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (July 18, 1995)
  • K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (April 25, 1995)
  • K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS (April 14, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)
  • K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (March 7, 1995)
  • K941030 — DRIED GRAM-NEGATIVE CEFPODOXIME (February 16, 1995)
  • K940917 — LORACARBEF GRAM-NAGATIVE PANELS (February 8, 1995)
  • K941459 — GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (February 3, 1995)
  • K941317 — DRIED GRAM NEGATIVE/CEFMETAZOLE (January 31, 1995)
  • K942089 — MICRODILUTION/LORACARBEF PANELS (January 9, 1995)

Other clearances for product code LKQ

  • K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUS (May 13, 2010)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K933549 — VIDAS CMV IGM ASSAY (August 2, 1994)
  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)
  • K900743 — CMV-IGM IFA TEST SYSTEM (April 26, 1990)
  • K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (July 25, 1989)
  • K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (July 14, 1989)
  • K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)

FDA data resources