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FDA 510(k) Application Details - K033187
Device Classification Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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510(K) Number
K033187
Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant
INTERLAB S.R.L.
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301-8804 US
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Contact
Gary Lehnus
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Regulation Number
866.5510
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Classification Product Code
CFF
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Date Received
10/01/2003
Decision Date
11/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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