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510(k) K925209

MUMPS STAT by Biowhittaker Molecular Applications, Inc. — Product Code LJY

K925209 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "MUMPS STAT". The FDA issued a decision of Substantially Equivalent on October 14, 1994. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
October 7, 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

Other clearances by Biowhittaker Molecular Applications, Inc.

  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)
  • K942361 — WHITSOFT (April 4, 1995)
  • K942250 — BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (April 4, 1995)
  • K942245 — BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (April 3, 1995)
  • K935618 — SPECIMEN TRANSPORT MEDIUM (April 21, 1994)
  • K932679 — RHEUMELISA II HISTONE ANTIBODY TEST KIT (August 23, 1993)
  • K930757 — RHEUMELISA II JO-1 ANTIBODY TEST KIT (March 26, 1993)
  • K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT (March 23, 1993)
  • K920753 — RF STAT IGM TEST KIT (March 30, 1992)

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)
  • 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