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510(k) K901805

REP(R) IMMUNOFIX by Helena Laboratories — Product Code DAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
April 20, 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

  • K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (April 27, 1993)
  • K905149 — TITAN GEL (January 3, 1991)
  • 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)