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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name formulations, balanced salt solutions
510(k) Number K844878
Device Name TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
Applicant
HAZLETON RESEARCH PRODUCTS, INC.
box 7200
denver,  PA  17517
Applicant Contact james k noel
Correspondent
HAZLETON RESEARCH PRODUCTS, INC.
box 7200
denver,  PA  17517
Correspondent Contact james k noel
Regulation Number864.2875
Classification Product Code
KIP  
Date Received12/17/1984
Decision Date 02/25/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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