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510(k) K851271

LEGIONELLA CULTURE CONFIRMATIN KIT by Gen-Probe, Inc. — Product Code GRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1985
Date Received
April 1, 1985
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

  • K834067 — LEGIONELLA DIFFERENTIATION DISK (January 3, 1984)
  • K802423 — PHADEBACT HAEMOPHILUS TEST (November 12, 1980)
  • K800493 — BACTOGEN-H. INFLUENZAE TYPE B (April 4, 1980)