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510(k) K971502

SERODIA TP-PA by Scimedx Tekfile Services — Product Code GMT

K971502 is an FDA 510(k) premarket notification submitted by Scimedx Tekfile Services for the device "SERODIA TP-PA". The FDA issued a decision of Substantially Equivalent on November 13, 1997. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1997
Date Received
April 24, 1997
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 for product code GMT

  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K911266 — MODIFIED PK TP CONTROL (May 7, 1991)
  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 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