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FDA 510(k) Application Details - K031965
Device Classification Name
Cryptosporidium Spp.
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510(K) Number
K031965
Device Name
Cryptosporidium Spp.
Applicant
REMEL INC
1400 UNITY ST. NORTHWEST
RAMSEY, MN 55303 US
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Contact
RICHARD TYSON
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Regulation Number
866.3220
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Classification Product Code
MHJ
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Date Received
06/26/2003
Decision Date
11/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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