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510(k) K914022

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

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

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  • 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)

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