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510(k) K905038

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

K905038 is an FDA 510(k) premarket notification submitted by Fujirebio America, Inc. for the device "OLYMPUS PK-TP ABSORBENT KIT". The FDA issued a decision of Substantially Equivalent on May 6, 1991. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Fujirebio America, Inc. has at least 1 other 510(k) clearance on record.

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.

  • K953066 — SERODIA ATG (August 14, 1995)

Other clearances for product code GMT

  • K971502 — SERODIA TP-PA (November 13, 1997)
  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K911266 — MODIFIED PK TP CONTROL (May 7, 1991)
  • 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)

FDA data resources