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510(k) K991074

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST by Intracel Corp. — Product Code MJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
March 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legionella, Spp., Elisa
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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  • K934965 — BINAX LEGIONELLA URINARY ANTIGEN EIA (September 20, 1994)
  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)