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510(k) K943843

VARICELISA, MODIFICATION by Biowhittaker Molecular Applications, Inc. — Product Code LFY

K943843 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "VARICELISA, MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 14, 1996. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1996
Date Received
July 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

Other clearances by Biowhittaker Molecular Applications, Inc.

  • 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)
  • K925209 — MUMPS STAT (October 14, 1994)
  • 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 LFY

  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG (March 11, 2015)
  • K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (July 5, 2007)
  • K061820 — DIASORIN LIAISON VZV IGG (February 26, 2007)
  • K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (December 5, 2005)
  • K984181 — THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM (January 22, 1999)
  • K981867 — IS-VZU IGG TEST SYSTEM (September 28, 1998)
  • K972295 — SERAQUEST VZV IGG (November 5, 1997)
  • K961012 — VZV IGG ELISA TEST SYSTEM (July 24, 1996)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)

FDA data resources