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510(k) K971857

MUMPS IGG ELISA TESTY by Gull Laboratories, Inc. — Product Code LJY

K971857 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "MUMPS IGG ELISA TESTY". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
May 20, 1997
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 Gull Laboratories, Inc.

  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K941624 — RUBELLA IGG ELISA TEST (August 4, 1995)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

Other clearances for product code LJY

  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K980059 — SERAQUEST MUMPS IGG (April 23, 1998)
  • 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