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510(k) K914022

SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS by Pharmacia Diagnostics, Inc. — Product Code LFY

K914022 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS". The FDA issued a decision of Substantially Equivalent on January 27, 1992. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1992
Date Received
September 9, 1991
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 Pharmacia Diagnostics, Inc.

  • K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, (February 7, 2006)
  • K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE (June 9, 2005)
  • K921011 — PHARMACIA CMV IGM ELISA (July 27, 1992)
  • K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (July 8, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)
  • K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT (June 25, 1991)
  • K902793 — RUBELLA IGG (July 31, 1990)
  • K902792 — TOXOPLASMA GONDII IGG (July 24, 1990)

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)
  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)

FDA data resources