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510(k) K896410

CELLOGNOST SYPHILIS H by Behring Diagnostics, Inc. — Product Code GMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
November 7, 1989
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

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Other clearances for product code GMT

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  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 1991)
  • K893124 — OLYMPUS PK(TM) TP (November 17, 1989)
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  • K791457 — AGGLUTINOTEST-SYPHILIS (September 24, 1979)
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