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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K033187
Device Name INTERLAB IMMUNOFIXATION TEST(S)
Applicant
Interlab S.R.L.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301 -8804
Applicant Contact Gary Lehnus
Correspondent
Interlab S.R.L.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301 -8804
Correspondent Contact Gary Lehnus
Regulation Number866.5510
Classification Product Code
CFF  
Subsequent Product Code
JKM  
Date Received10/01/2003
Decision Date 11/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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