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510(k) K991274

MUMPS IGG ELISA TEST SYSTEM by Columbia Bioscience, Inc. — Product Code LJY

K991274 is an FDA 510(k) premarket notification submitted by Columbia Bioscience, Inc. for the device "MUMPS IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Columbia Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
April 13, 1999
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

Other clearances by Columbia Bioscience, Inc.

  • K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM (September 3, 1999)
  • K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEM (February 2, 1999)
  • K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM (December 16, 1998)
  • K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (December 16, 1998)
  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
  • K982348 — EBNA-1 IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982350 — EA-D IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982352 — VCA IGM ELISA TEST SYSTEM (November 25, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)
  • K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM (November 18, 1998)

Other clearances for product code LJY

  • 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)
  • K923903 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (August 9, 1993)
  • K897006 — PHARMACIA MUMPS IGG ELISA (July 26, 1990)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)

FDA data resources