FDA 510(k) Application Details - K920370

Device Classification Name Method, Immunodiffusion, Immunoglobulins (G, A, M)

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510(K) Number K920370
Device Name Method, Immunodiffusion, Immunoglobulins (G, A, M)
Applicant ISOTYPES, INC.
P.O. BOX 7022
NEWARK, DE US
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Contact BARRY F CRISPIN
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Regulation Number 866.5510

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Classification Product Code CGM
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Date Received 01/28/1992
Decision Date 03/11/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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