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510(k) K897006

PHARMACIA MUMPS IGG ELISA by Pharmacia Eni Diagnostics, Inc. — Product Code LJY

K897006 is an FDA 510(k) premarket notification submitted by Pharmacia Eni Diagnostics, Inc. for the device "PHARMACIA MUMPS IGG ELISA". The FDA issued a decision of Substantially Equivalent on July 26, 1990. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Pharmacia Eni Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1990
Date Received
December 18, 1989
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 Pharmacia Eni Diagnostics, Inc.

  • K894503 — GEMTAB SYSTEM (September 5, 1989)

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)
  • K923903 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (August 9, 1993)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)

FDA data resources