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510(k) K990998

POLYSLIT IFE KIT by Helena Laboratories — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1999
Date Received
March 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (October 13, 2011)
  • K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100 (April 17, 2009)