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510(k) K980059

SERAQUEST MUMPS IGG by Quest Intl., Inc. — Product Code LJY

K980059 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "SERAQUEST MUMPS IGG". The FDA issued a decision of Substantially Equivalent on April 23, 1998. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Quest Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1998
Date Received
January 7, 1998
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 Quest Intl., Inc.

  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (February 6, 2003)
  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (November 27, 2000)
  • K991975 — SERAQUEST EB NA IGG (November 2, 1999)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)

Other clearances for product code LJY

  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • 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