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510(k) K923903

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA by Biomerieux Vitek, Inc. — Product Code LJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
August 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

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  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)

Other clearances for product code LJY

  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K980059 — SERAQUEST MUMPS IGG (April 23, 1998)
  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K961204 — MUMPS IGG TEST (July 18, 1996)
  • K925209 — MUMPS STAT (October 14, 1994)
  • K897006 — PHARMACIA MUMPS IGG ELISA (July 26, 1990)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)