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510(k) K931247

TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 by Helena Laboratories — Product Code DAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1993
Date Received
March 11, 1993
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

  • K905149 — TITAN GEL (January 3, 1991)
  • 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)