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510(k) K905038

OLYMPUS PK-TP ABSORBENT KIT by Fujirebio America, Inc. — Product Code GMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1991
Date Received
November 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Fujirebio America, Inc.

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  • K896410 — CELLOGNOST SYPHILIS H (May 15, 1990)
  • K893124 — OLYMPUS PK(TM) TP (November 17, 1989)
  • K791897 — BACTO-HATTS (November 13, 1979)
  • K791457 — AGGLUTINOTEST-SYPHILIS (September 24, 1979)
  • K760098 — REAGENT, VDRL (August 3, 1976)