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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K840261
Device Name CAL-CHEX, A HEMATOLOGY CALIBRATOR
Applicant
Streck Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Streck Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received01/05/1984
Decision Date 02/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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