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FDA 510(k) Application Details - K971951
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
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510(K) Number
K971951
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE, CO 80033 US
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Contact
LINDA K DILLON
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Regulation Number
866.1640
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Classification Product Code
JWY
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More FDA Info for this Product Code
Date Received
05/28/1997
Decision Date
08/15/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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