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510(k) K905149

TITAN GEL by Helena Laboratories — Product Code DAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gamma Globulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code DAH

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  • K901805 — REP(R) IMMUNOFIX (June 6, 1990)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN G (September 7, 1988)
  • K854944 — TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (August 27, 1986)
  • K862184 — DAKO ITA, IMMUNOGLOBULIN M (IGM) (August 19, 1986)