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510(k) K834067

LEGIONELLA DIFFERENTIATION DISK by Remel Co. — Product Code GRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
November 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Hemophilus Spp.
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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Other clearances for product code GRO

  • K851271 — LEGIONELLA CULTURE CONFIRMATIN KIT (July 8, 1985)
  • K802423 — PHADEBACT HAEMOPHILUS TEST (November 12, 1980)
  • K800493 — BACTOGEN-H. INFLUENZAE TYPE B (April 4, 1980)