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510(k) K922334

BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA by Baxter Diagnostics, Inc. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1992
Date Received
May 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Device Class
Class II
Regulation Number
866.3305
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 LGC

  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (April 18, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)
  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYM (September 3, 1999)
  • K983886 — POCKIT HSV 2 RAPID TEST (August 19, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (March 18, 1999)
  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)