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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name discs, strips and reagents, microorganism differentiation
510(k) Number K921583
Device Name DRYSLIDE(TM), PYR
Applicant
DIFCO LABORATORIES, INC.
P.O. BOX 331058
DETROIT,  MI  48232 -7058
Applicant Contact DAVID W GATES
Correspondent
DIFCO LABORATORIES, INC.
P.O. BOX 331058
DETROIT,  MI  48232 -7058
Correspondent Contact DAVID W GATES
Regulation Number866.2660
Classification Product Code
JTO  
Date Received03/09/1992
Decision Date 06/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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